DyslipidemiaPhase 3FOURIERNCT01764633
Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk
A Phase 3 study testing Evolocumab in people with Dyslipidemia, run by Amgen at 1,284 sites in 49 countries.
Trial summary
The primary objective was to evaluate the effect of treatment with evolocumab, compared with placebo, on the risk for cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization, whichever occurs first, in patients with clinically evident cardiovascular… Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- Evolocumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27,564 participants
- Where
- 1,284 sitesin 49 countries
- Study dates
- 8 Feb 2013to 11 Nov 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥ 40 to ≤ 85 years of age
- History of clinically evident cardiovascular disease at high risk for a recurrent event
- Fasting low-density lipoprotein cholesterol (LDL-C) ≥ 70 mg/dL (≥ 1.8 mmol/L) ) or non-high-density lipoprotein cholesterol (non-HDL-C) ≥ 100 mg/dL (> 2.6 mmol/L)
- Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L)
Who cannot join
- New York Heart Association (NYHA) class III or IV, or last known left ventricular ejection fraction < 30%
- Uncontrolled hypertension
- Uncontrolled or recurrent ventricular tachycardia
- Untreated hyperthyroidism or hypothyroidism
- Homozygous familial hypercholesterolemia
- LDL or plasma apheresis
Trial locations and contacts
1,284 sites in 49 countries.
1258 sites in 49 countries
United States300 sites
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Abington, Pennsylvania, 19001
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Addison, Illinois, 60101
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Albany, New York, 12208
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Alhambra, California, 91801
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Altoona, Pennsylvania, 16602
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Ames, Iowa, 50010
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Anchorage, Alaska, 99508
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Anderson, South Carolina, 29621
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Ann Arbor, Michigan, 48106
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Annapolis, Maryland, 21401
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Arlington, Texas, 76012
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Asheville, North Carolina, 28801
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Asheville, North Carolina, 28805
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Athens, Georgia, 30606
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Atlanta, Georgia, 30342
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Atlantis, Florida, 33462
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Auburn, Maine, 04210
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Augusta, Georgia, 30909
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Aurora, Colorado, 80012
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Austin, Texas, 78758
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Aventura, Florida, 33180
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Ayer, Massachusetts, 01432
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Baltimore, Maryland, 21201
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Baltimore, Maryland, 21204
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Baltimore, Maryland, 21236
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Baltimore, Maryland, 21237
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Bangor, Maine, 04401
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Banning, California, 92220
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Baton Rouge, Louisiana, 70808
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Bay Pines, Florida, 33744
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Belleville, Illinois, 62220
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Bend, Oregon, 97701
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Beverly Hills, California, 90211
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Biddeford, Maine, 04005
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Billerica, Massachusetts, 01821
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Billings, Montana, 59101
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Billings, Montana, 59102
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Birmingham, Alabama, 35235
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Birmingham, Alabama, 35294
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Boise, Idaho, 83704
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Boise, Idaho, 83706
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Boynton Beach, Florida, 33472
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Bradenton, Florida, 34205
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Bridgeport, Connecticut, 06610
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Buffalo, New York, 14203
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Buffalo, New York, 14215
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Burke, Virginia, 22015
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Calabash, North Carolina, 28467
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Camp Hill, Pennsylvania, 17011
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Canton, Ohio, 44710
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Cary, North Carolina, 27518
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Chambersburg, Pennsylvania, 17201
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Charleston, South Carolina, 29407
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Charleston, South Carolina, 29425
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Charlotte, North Carolina, 28204
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Charlotte, North Carolina, 28277
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Charlotte Hall, Maryland, 20622
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Chicago, Illinois, 60616
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Cincinnati, Ohio, 45219
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Cincinnati, Ohio, 45224
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Clearwater, Florida, 33756
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Cleveland, Ohio, 44195
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Coeur d'Alene, Idaho, 83814
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Colorado Springs, Colorado, 80907
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Colorado Springs, Colorado, 80909
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Columbia, Maryland, 21044
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Columbia, Maryland, 21045
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Columbia, Missouri, 65212
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Columbia, South Carolina, 29204
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Columbus, Ohio, 43201
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Columbus, Ohio, 43215
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Cortlandt Manor, New York, 10567
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Covington, Louisiana, 70433
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Cranston, Rhode Island, 02920
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Crystal River, Florida, 34429
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Cumberland, Rhode Island, 02864
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Dallas, Texas, 75216
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Danville, Virginia, 24541
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Dayton, Ohio, 45414
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Daytona Beach, Florida, 32117
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Dearborn, Michigan, 48124
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Deerfield Beach, Florida, 33442
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Delray Beach, Florida, 33484
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Denver, Colorado, 80218
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Des Moines, Iowa, 50266
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Dunwoody, Georgia, 30338
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Durham, North Carolina, 27710
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East Point, Georgia, 30344
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Eatonton, Georgia, 31024
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Edgewater, Florida, 32141
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Elizabeth, New Jersey, 07202
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Elyria, Ohio, 44035
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Encino, California, 91436
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Escondido, California, 92029
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Evansville, Indiana, 47714
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Fall River, Massachusetts, 02720
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Falls Church, Virginia, 22042
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Fargo, North Dakota, 58122
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Feasterville, Pennsylvania, 19053
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Federal Way, Washington, 98003
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Fleming Island, Florida, 32003
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Flint, Michigan, 48532
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Fort Lauderdale, Florida, 33308
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Fountain Inn, South Carolina, 29644
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Gainesville, Georgia, 30501
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Garfield Heights, Ohio, 44125
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Germantown, Tennessee, 38138
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Glendale, Arizona, 85306
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Glendale, California, 91204
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Grand Forks, North Dakota, 58201
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Grandville, Michigan, 49418
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Grapevine, Texas, 76051
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Great Falls, Montana, 59405
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Greeley, Colorado, 80631
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Green Bay, Wisconsin, 54301
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Greensboro, North Carolina, 27408
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Hammond, Louisiana, 70403
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Harbor City, California, 90710
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Haverhill, Massachusetts, 01830
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Hazel Crest, Illinois, 60429
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Hickory, North Carolina, 28601
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High Point, North Carolina, 27262
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Hollywood, Florida, 33021
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Hollywood, Maryland, 20636
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Hopewell, Virginia, 23860
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Houston, Texas, 77025
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Houston, Texas, 77030
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Houston, Texas, 77070
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Houston, Texas, 77074
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Huntington Beach, California, 92646
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Huntsville, Alabama, 35801
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Hutchinson, Kansas, 67502
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Hyannis, Massachusetts, 02601
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Indiana, Pennsylvania, 15701
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Indianapolis, Indiana, 46227
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Indianapolis, Indiana, 46237
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Indianapolis, Indiana, 46260
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Iowa City, Iowa, 52242
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Jackson, Tennessee, 38305
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Jacksonville, Florida, 32216
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Jacksonville Beach, Florida, 32250
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Jefferson City, Missouri, 65109
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Jersey Shore, Pennsylvania, 17740
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Jerseyville, Illinois, 62052
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Johnston, Rhode Island, 02919
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Kalispell, Montana, 59901
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Kansas City, Kansas, 66160
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Kansas City, Missouri, 64128
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Kerrville, Texas, 78028
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Kingston, New York, 12401
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Lafayette, Louisiana, 70508
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Laguna Hills, California, 92653
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Lakeland, Florida, 33805
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Lansing, Michigan, 48912
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Largo, Florida, 33777
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Las Vegas, Nevada, 89128
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Layton, Utah, 84041
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Lenoir, North Carolina, 28645
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Lexington, Kentucky, 40504
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Lincoln, Nebraska, 68506
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Littleton, Colorado, 80120
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Long Beach, California, 90807
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Long Beach, California, 90822
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Longmont, Colorado, 80501
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Longview, Texas, 75605
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Los Alamitos, California, 90720
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Los Angeles, California, 90033
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Los Angeles, California, 90048
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Macon, Georgia, 31201
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Madison, Wisconsin, 53713
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Marion, Ohio, 43302
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Marshfield, Wisconsin, 54449
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Melbourne, Florida, 32901
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Memphis, Tennessee, 38112
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Meridian, Idaho, 83642
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Metairie, Louisiana, 70006
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Miami, Florida, 33144
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Miami, Florida, 33155
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Miami, Florida, 33173
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Minneapolis, Minnesota, 55417
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Missoula, Montana, 59802
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Mobile, Alabama, 36608
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Moncks Corner, South Carolina, 29461
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Monroe, Louisiana, 71203
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Mooresville, North Carolina, 28117
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Mt. Pleasant, South Carolina, 29464
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Munster, Indiana, 46321
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Murray, Utah, 84107
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Muskegon, Michigan, 49444
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Nampa, Idaho, 83686
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Nashville, Tennessee, 37203
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Nashville, Tennessee, 37205
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Nashville, Tennessee, 37208
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Natchitoches, Louisiana, 71457
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New Hyde Park, New York, 11042
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New Port Richey, Florida, 34653
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New Windsor, New York, 12553
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New York, New York, 10021
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New York, New York, 10029
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New York, New York, 10033
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New York, New York, 10036
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Newark, Delaware, 19718
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Newport Beach, California, 92663
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Newton, Massachusetts, 02459
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Norristown, Pennsylvania, 19401
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North Myrtle Beach, South Carolina, 29582
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Novi, Michigan, 48374
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Oceanside, California, 92056
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Odessa, Texas, 79761
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Oklahoma City, Oklahoma, 73135
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Old Point Station, South Carolina, 29707
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Olive Branch, Mississippi, 38654
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Omaha, Nebraska, 68131
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Orangeburg, South Carolina, 29118
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Orlando, Florida, 32806
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Overland Park, Kansas, 66210
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Owensboro, Kentucky, 42303
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Oxnard, California, 93030
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Palm Harbor, Florida, 34684
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Palm Springs, California, 92262
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Pawtucket, Rhode Island, 02860
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Pembroke Pines, Florida, 33024
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Pembroke Pines, Florida, 33028
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Pensacola, Florida, 32501
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Philadelphia, Pennsylvania, 19104
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Philadelphia, Pennsylvania, 19107
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Philadelphia, Pennsylvania, 19152
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Phoenix, Arizona, 85015
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Phoenix, Arizona, 85018
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Phoenix, Arizona, 85054
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Pittsburgh, Pennsylvania, 15206
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Plano, Texas, 75023
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Plano, Texas, 75024
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Ponte Vedra, Florida, 32081
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Port Charlotte, Florida, 33952
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Portland, Maine, 04101
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Portland, Oregon, 97225
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Portland, Oregon, 97239
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Pryor, Oklahoma, 74362
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Quincy, Illinois, 62301
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Quincy, Massachusetts, 02169
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Raleigh, North Carolina, 27609
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Rapid City, South Dakota, 57701
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Richmond, Virginia, 23219
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Richmond, Virginia, 23294
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Roanoke, Virginia, 24014
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Rochester, New York, 14609
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Roseville, California, 95661
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Sacramento, California, 95816
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Safety Harbor, Florida, 34695
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Saginaw, Michigan, 48601
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Saginaw, Michigan, 48604
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Saint Cloud, Minnesota, 56303
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Saint Paul, Minnesota, 55102
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Salisbury, Maryland, 21804
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San Antonio, Texas, 78229
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San Diego, California, 92103
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San Diego, California, 92161
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San Pedro, California, 90732
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Sandusky, Ohio, 44870
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Sanford, Florida, 32771
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Santa Ana, California, 92704
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Sarasota, Florida, 34232
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Sarasota, Florida, 34239
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Savannah, Georgia, 31406
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Seaford, Delaware, 19973
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Seattle, Washington, 98104
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Seattle, Washington, 98195
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Selah, Washington, 98942
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Sellersville, Pennsylvania, 18960
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Slidell, Louisiana, 70458
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Springfield, Massachusetts, 01199
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Springfield, Ohio, 45505
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St Louis, Missouri, 63117
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St Louis, Missouri, 63128
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St. Petersburg, Florida, 33709
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St. Petersburg, Florida, 33713
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Statesville, North Carolina, 28625
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Stony Brook, New York, 11794
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Suffolk, Virginia, 23435
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Sugar Land, Texas, 77478
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Suwanee, Georgia, 30024
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Syracuse, New York, 13202
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Tabor City, North Carolina, 28463
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Tampa, Florida, 33614
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Tarzana, California, 91356
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Thousand Oaks, California, 91360
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Toledo, Ohio, 43608
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Toledo, Ohio, 43615
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Toledo, Ohio, 43623
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Tomball, Texas, 77375
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Torrance, California, 90502
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Torrance, California, 90503
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Towson, Maryland, 21204
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Traverse City, Michigan, 49684
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Troy, New York, 12180
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Tucson, Arizona, 85712
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Tucson, Arizona, 85723
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Tullahoma, Tennessee, 37388
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Tulsa, Oklahoma, 74133
United Kingdom76 sites
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Aberdeen, AB25 2ZN
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Addlestone, KT15 2BH
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Arnsley, S75 2EP
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Basildon, SS16 5NL
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Belfast, BT12 6BA
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Belfast, BT13 3BW
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Belfast, BT16 1RH
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Belfast, BT7 2EB
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Birmingham, B15 2SQ
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Birmingham, B18 7QH
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Blackpool, FY3 8NR
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Bournemouth, BH7 7DW
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Bury St Edmunds, IP33 2QZ
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Canterbury, CT1 3NG
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Cardiff, CF14 5GJ
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Cardiff, CF4 4XW
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Chesterfield, S40 4AA
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Chippenham, SN15 2SB
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Chorley, PR7 7NA
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Colchester, CO4 5JL
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Cottingham, HU16 5JQ
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Coventry, CV4 7AL
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Dundee, DD1 9SY
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Edinburgh, EH16 4SB
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Glasgow, G20 0SP
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Glasgow, G45 9AW
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Glasgow, G51 4TF
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Harrow, HA1 3UJ
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Haxey, Doncaster, DN9 2HY
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Hayle, TR27 5DT
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Hexham, NE46 1QJ
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Hitchin, SG4 9TH
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Inverness, IV2 3JH
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Leeds, LS1 3EX
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Leicester, LE3 9QP
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Liverpool, L22 0LG
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Liverpool, L7 8XP
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Liverpool, L9 7AL
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London, EC1M 6BQ
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London, SE1 7EH
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London, W12 0HS
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Luton, LU4 0DZ
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Manchester, M15 6SX
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Manchester, M23 9LT
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Metropolitan Borough of Wirral, CH49 5PE
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Middlesbrough, TS4 3BW
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Newport, PO30 5TG
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Northampton, NN1 5BD
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Nottingham, NG5 1PB
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Nuneaton, CV10 7DJ
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Penzance, TR18 2RE
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Penzance, TR18 4EL
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Penzance, TR19 7HX
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Plymouth, PL6 8DH
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Portsmouth, PO6 3LY
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Reading, RG2 0TF
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Rotherham, S60 2UD
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Royal Leamington Spa, CV34 4RA
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Rugby, CV22 5PX
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Saint Leonards-on-Sea, TN37 7RD
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Sandbach, CW11 1EQ
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Sheffield, S5 7AU
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St Austell, PL26 7RL
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Stevenage, SG1 4AB
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Stoke-on-Trent, ST4 6DG
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Swansea, SA2 8PP
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Telford, TF1 6TF
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Torquay, TQ2 7AA
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Welwyn Garden City, AL7 4HQ
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West Bromwich, B71 4HJ
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Whitby, YO21 1SD
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Wiltshire, BA15 1DQ
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Wolverhampton, WV10 0QP
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Worcester, WR5 1DD
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Wrexham, LL13 7TD
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York, YO31 8HE
Japan65 sites
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Asahikawa-shi, Hokkaido, 070-0054
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Bunkyo-ku, Tokyo, 113-8431
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Chiba, Chiba, 260-8606
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Chikushi-gun, Fukuoka, 811-1244
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Chikushino-shi, Fukuoka, 818-8516
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Chuo-ku, Tokyo, 103-0027
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Chuo-shi, Yamanashi, 409-3898
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Fujisawa-shi, Kanagawa, 251-8550
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Fukuoka, Fukuoka, 814-0180
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Fukuoka, Fukuoka, 814-8522
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Hachioji-shi, Tokyo, 192-0918
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Hamada-shi, Shimane, 697-8511
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Higashisonogi-gun, Nagasaki, 859-3615
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Himeji-shi, Hyōgo, 672-8043
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Ichinomiya-shi, Aichi-ken, 491-8551
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Itoshima-shi, Fukuoka, 819-1104
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Kanazawa, Ishikawa-ken, 920-8650
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Kasugai-shi, Aichi-ken, 487-0031
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Kawaguchi-shi, Saitama, 332-8558
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Kobe, Hyōgo, 654-0155
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Koga-shi, Fukuoka, 811-3195
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Komatsushima-shi, Tokushima, 773-8502
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Koriyama-shi, Fukushima, 963-8052
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Kumamoto, Kumamoto, 860-8556
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Kure-shi, Hiroshima, 737-0023
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Kurume-shi, Fukuoka, 830-0011
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Kurume-shi, Fukuoka, 830-8577
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Kusatsu-shi, Shiga, 525-8585
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Kyoto, Kyoto, 615-0035
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Matsudo-shi, Chiba, 271-0077
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Musashimurayama-shi, Tokyo, 208-0011
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Nagasaki, Nagasaki, 850-8555
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Nagoya, Aichi-ken, 451-8511
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Nagoya, Aichi-ken, 455-8530
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Nagoya, Aichi-ken, 457-8511
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Nagoya, Aichi-ken, 460-0001
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Niihama-shi, Ehime, 792-8586
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Odawara-shi, Kanagawa, 250-8558
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Ōita, Oita Prefecture, 870-0263
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Okawa-shi, Fukuoka, 831-0016
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Okayama, Okayama-ken, 702-8055
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Okinawa-shi, Okinawa, 904-8585
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Omura-shi, Nagasaki, 856-8562
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Osaka, Osaka, 530-0001
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Osaka, Osaka, 530-8480
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Osaka, Osaka, 543-0035
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Osaka, Osaka, 550-0022
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Otake-shi, Hiroshima, 739-0651
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Saga, Saga-ken, 840-8571
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Saga, Saga-ken, 849-0917
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Sagamihara-shi, Kanagawa, 252-0375
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Saijo-shi, Ehime, 793-0030
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Sanuki-shi, Kagawa-ken, 769-2393
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Sapporo, Hokkaido, 060-0031
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Sendai, Miyagi, 983-8520
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Shimajiri-gun, Okinawa, 901-0493
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Sunto-gun, Shizuoka, 411-8611
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tabashi City, Tokyo, 173-8606
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tabashi City, Tokyo, 173-8610
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Tachikawa-shi, Tokyo, 190-0014
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Toride-shi, Ibaraki, 302-0022
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Toyohashi, Aichi-ken, 440-8510
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Tsukuba, Ibaraki, 305-8558
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Urasoe-shi, Okinawa, 901-2132
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Yokohama, Kanagawa, 245-8575
Poland54 sites
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Bielsko-Biala, 43-316
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Bydgoszcz, 85-094
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Gdansk, 80-542
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Gdansk, 80-952
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Gdynia, 81-384
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Gdynia, 81-402
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Gdynia, 81-472
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Giżycko, 11-500
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Jelenia Góra, 58-506
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Katowice, 40-018
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Katowice, 40-040
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Katowice, 40-084
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Kielce, 25-020
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Krakow, 30-001
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Krakow, 30-347
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Krakow, 31-202
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Krakow, 31-216
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Krakow, 31-315
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Krakow, 32-082
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Lodz, 90-368
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Lodz, 90-549
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Lodz, 91-347
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Lodz, 93-530
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Lublin, 20-045
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Lublin, 20-080
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Lublin, 20-857
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Nowa Sól, 67-100
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Nysa, 48-300
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Olsztyn, 10-010
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Płock, 09-402
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Poznan, 60-702
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Poznan, 61-113
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Poznan, 61-853
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Pszczyna, 43-200
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Puławy, 24-100
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Ruda Śląska, 41-709
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Skierniewice, 96-100
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Starogard Gdański, 83-200
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Staszów, 28-200
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Świdnik, 21-040
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Tarnów, 33-100
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Torun, 87-100
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Warsaw, 01-192
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Warsaw, 01-809
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Warsaw, 02-097
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Warsaw, 02-507
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Warsaw, 04-628
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Warsaw, 04-730
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Warsaw, 04-749
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Włocławek, 87-800
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Wroclaw, 50-088
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Wroclaw, 50-349
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Wroclaw, 51-685
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Zamość, 22-400
Czechia52 sites
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Benátky nad Jizerou, 294 71
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Benešov, 256 01
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Beroun, 266 01
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Bílovec, 743 01
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Brandýs nad Labem, 250 01
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Brno, 602 00
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Brno, 603 00
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Brno, 625 00
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Brno, 636 00
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Brno, 638 00
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Brno, 656 91
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České Budějovice, 370 04
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Český Krumlov, 381 01
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Chomutov, 430 02
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Havlíčkův Brod, 580 22
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Hodonín, 695 01
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Hradec Králové, 500 02
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Hranice, 753 22
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Jihlava, 586 01
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Kladno, 272 59
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Klatovy IV, 339 01
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Kutná Hora, 284 01
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Liberec, 460 63
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Litoměřice, 412 01
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Litomyšl, 570 14
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Milevsko, 399 01
Research Site
Mladá Boleslav, 293 01
Research Site
Mohelnice, 789 85
Research Site
Moravské Budějovice, 676 02
Research Site
Nymburk, 288 01
Research Site
Olomouc, 779 00
Research Site
Ostrava, 728 80
Research Site
Ostrava-Poruba, 708 00
Research Site
Pardubice, 530 02
Research Site
Pilsen, 305 99
Research Site
Polička, 572 01
Research Site
Prachatice, 383 01
Research Site
Prague, 101 00
Research Site
Prague, 128 08
Research Site
Prague, 130 00
Research Site
Prague, 140 21
Research Site
Prague, 140 59
Research Site
Prague, 150 06
Research Site
Prague, 158 00
Research Site
Praha 5 - Smichov, 150 00
Research Site
Přerov, 750 02
Research Site
Pribram VIII, 261 01
Research Site
Svitavy, 568 25
Research Site
Teplice, 415 01
Research Site
Uherské Hradiště, 686 01
Research Site
Zábřeh nad Odrou, 700 30
Research Site
Znojmo, 669 02
Canada46 sites
Research Site
Brampton, Ontario, L6Z 4N5
Research Site
Calgary, Alberta, T2N 4Z6
Research Site
Cambridge, Ontario, N1R 6V6
Research Site
Chicoutimi, Quebec, G7H 7K9
Research Site
Gatineau, Quebec, J8Y 6S8
Research Site
Granby, Quebec, J2G 8Z9
Research Site
Greenfield Park, Quebec, J4V 2G8
Research Site
Halifax, Nova Scotia, B3H 3A7
Research Site
Hamilton, Ontario, L8L 2X2
Research Site
Kelowna, British Columbia, V1Y 1V6
Research Site
Lachine, Quebec, H8S 2E4
Research Site
London, Ontario, N6A 5K8
Research Site
London, Ontario, N6C 0A7
Research Site
Longueuil, Quebec, J4M 2X1
Research Site
Montreal, Quebec, H1T 3Y7
Research Site
Montreal, Quebec, H1Y 3L1
Research Site
Montreal, Quebec, H2W 1R7
Research Site
Montreal, Quebec, H2W 1T8
Research Site
Montreal, Quebec, H3G 1A4
Research Site
Montreal, Quebec, H4A 3J1
Research Site
New Westminster, British Columbia, V3L 3W4
Research Site
Newmarket, Ontario, L3Y 5G8
Research Site
Newmarket, Ontario, L3Y 8C3
Research Site
Oshawa, Ontario, L1J 2J9
Research Site
Oshawa, Ontario, L1J 2K1
Research Site
Ottawa, Ontario, K1Y 4W7
Research Site
Peterborough, Ontario, K9J 0B2
Research Site
Pointe-Claire, Quebec, H9R 3J1
Research Site
Québec, Quebec, G1V 4G5
Research Site
Québec, Quebec, G1V 4W2
Research Site
Regina, Saskatchewan, S4P 0W5
Research Site
Saint-Charles-Borromée, Quebec, J6E 6J2
Research Site
Saint-Jean-sur-Richelieu, Quebec, J3A 1C3
Research Site
Saint-Jérôme, Quebec, J7Z 5T3
Research Site
Sarnia, Ontario, N7T 4X3
Research Site
Scarborough Village, Ontario, M1E 5E9
Research Site
Scarborough Village, Ontario, M1P 2T7
Research Site
St. John's, Newfoundland and Labrador, A1A 3R5
Research Site
St. John's, Newfoundland and Labrador, A1B 3V6
Research Site
Strathroy, Ontario, N7G 1Y7
Research Site
Terrebonne, Quebec, J6V 2H2
Research Site
Thunder Bay, Ontario, P7B 6V4
Research Site
Toronto, Ontario, M5C 2T2
Research Site
Toronto, Ontario, M5T 3A9
Research Site
Vancouver, British Columbia, V6Z 1Y6
Research Site
Westmout, Quebec, H3Z 1E5
China37 sites
Research Site
Baotou, Inner Mongolia, 014010
Research Site
Beijing, Beijing Municipality, 100037
Research Site
Beijing, Beijing Municipality, 100191
Research Site
Beijing, 100020
Research Site
Changchun, Jilin, 130011
Research Site
Changchun, Jilin, 130021
Research Site
Changchun, Jilin, 130033
Research Site
Changde, Hunan, 415003
Research Site
Changsha, Hunan, 410004
Research Site
Changsha, Hunan, 410005
Research Site
Changsha, Hunan, 410008
Research Site
Changsha, Hunan, 410013
Research Site
Dalian, Liaoning, 116027
Research Site
Guangzhou, Guangdong, 510080
Research Site
Hangzhou, Zhejiang, 310013
Research Site
Harbin, Heilongjiang, 150001
Research Site
Hohhot, Inner Mongolia, 010020
Research Site
Linhai, Zhejiang, 317000
Research Site
Ningbo, Zhejiang, 315010
Research Site
Qingdao, Shandong, 266003
Research Site
Shenyang, Liaoning, 110016
Research Site
Siping, Jilin, 136000
Research Site
Suzhou, Jiangsu, 215000
Research Site
Taiyuan, Shanxi, 030009
Research Site
Tianjin, Tianjin Municipality, 300052
Research Site
Tianjin, Tianjin Municipality, 300120
Research Site
Tianjin, 300211
Research Site
Ürümqi, Xinjiang, 830054
Research Site
Wenzhou, Zhejiang, 325000
Research Site
Wuhan, Hubei, 430014
Research Site
Wuhan, Hubei, 430030
Research Site
Wuxi, Jiangsu, 214023
Research Site
Xiangtan, Hunan, 411100
Research Site
Xuzhou, Jiangsu, 221006
Research Site
Yinchuan, Ningxia, 750004
Research Site
Zhengzhou, Henan, 450052
Research Site
Zhuzhou, Hunan, 412000
Germany33 sites
Research Site
Bad Krozingen, 79189
Research Site
Berlin, 10787
Research Site
Berlin, 12351
Research Site
Berlin, 12559
Research Site
Berlin, 13353
Research Site
Bochum, 44787
Research Site
Cologne, 50937
Research Site
Demmin, 17109
Research Site
Dortmund, 44137
Research Site
Dresden, 01307
Research Site
Düsseldorf, 40210
Research Site
Frankfurt am Main, 60596
Research Site
Giessen, 35392
Research Site
Hamburg, 20099
Research Site
Hamburg, 20246
Research Site
Hanover, 30159
Research Site
Heidelberg, 69120
Research Site
Ingelheim, 55218
Research Site
Kassel, 34121
Research Site
Lahr, 77933
Research Site
Leipzig, 04103
Research Site
Limburg, 65549
Research Site
Magdeburg, 39120
Research Site
Mainz, 55131
Research Site
Mannheim, 68165
Research Site
Marburg, 35043
Research Site
München, 80636
Research Site
München, 80638
Research Site
Regensburg, 93053
Research Site
Stuttgart, 70376
Research Site
Ulm, 89081
Research Site
Witten, 58455
Research Site
Wuppertal, 42117
Netherlands33 sites
Research Site
Alkmaar, 1815 JD
Research Site
Almelo, 7609 PP
Research Site
Amstelveen, 1186 AM
Research Site
Amsterdam, 1061 AE
Research Site
Amsterdam, 1091 AC
Research Site
Arnhem, 6815 AD
Research Site
Beverwijk, 1942 LE
Research Site
Den Helder, 1782 GZ
Research Site
Deventer, 7416 SE
Research Site
Doetinchem, 7009 BL
Research Site
Ede, 6716 RP
Research Site
Eindhoven, 5623 EJ
Research Site
Eindhoven, 5631 BM
Research Site
Goes, 4462 RA
Research Site
Gorinchem, 4204 AA
Research Site
Gouda, 2803 HH
Research Site
Harderwijk, 3844 DG
Research Site
Helmond, 5707 HA
Research Site
Hoogeveen, 7909 AA
Research Site
Hoorn, 1624 NP
Research Site
Leiden, 2333 ZA
Research Site
Leiden, 2334 CK
Research Site
Nieuwegein, 3435 CM
Research Site
Nijmegen, 6532 SZ
Research Site
Purmerend, 1440 AG
Research Site
Rotterdam, 3045 PM
Research Site
Rotterdam, 3079 DZ
Research Site
Sneek, 8601 ZK
Research Site
Tiel, 4002 WP
Research Site
Tilburg, 5042 AD
Research Site
Uden, 5406 PT
Research Site
Veldhoven, 5504 DB
Research Site
Venlo, 5912 BL
Russia33 sites
Research Site
Barnaul, 656038
Research Site
Barnaul, 656055
Research Site
Ivanovo, 153012
Research Site
Izhevsk, 426063
Research Site
Kemerovo, 650002
Research Site
Kemerovo, 650099
Research Site
Kirov, 610014
Research Site
Moscow, 101990
Research Site
Moscow, 111020
Research Site
Moscow, 111539
Research Site
Moscow, 117292
Research Site
Moscow, 117342
Research Site
Moscow, 119620
Research Site
Moscow, 121552
Research Site
Moscow, 129090
Research Site
Nizhny Novgorod, 603076
Research Site
Novosibirsk, 630047
Research Site
Novosibirsk, 630089
Research Site
Omsk, 644018
Research Site
Pushkin, 196601
Research Site
Saint Petersburg, 191015
Research Site
Saint Petersburg, 192289
Research Site
Saint Petersburg, 194156
Research Site
Saint Petersburg, 195112
Research Site
Saint Petersburg, 197022
Research Site
Saint Petersburg, 197341
Research Site
Saint Petersburg, 198205
Research Site
Saint Petersburg, 199106
Research Site
Saratov, 410054
Research Site
Tomsk, 634012
Research Site
Tyumen, 625000
Research Site
Yekaterinburg, 620102
Research Site
Yekaterinburg, 620144
France32 sites
Research Site
Besançon, 25030
Research Site
Brest, 29200
Research Site
Chambray-lès-Tours, 37170
Research Site
Clermont-Ferrand, 63000
Research Site
Créteil, 94010
Research Site
Dijon, 21079
Research Site
Le Coudray, 28630
Research Site
Lille, 59037
Research Site
Lyon, 69007
Research Site
Marseille, 13285
Research Site
Metz, 57085
Research Site
Montpellier, 34094
Research Site
Montpellier, 34295
Research Site
Nantes, 44093
Research Site
Nantes, 44202
Research Site
Nice, 06000
Research Site
Nîmes, 30029
Research Site
Orléans, 45067
Research Site
Paris, 75010
Research Site
Paris, 75013
Research Site
Paris, 75015
Research Site
Pau, 64000
Research Site
Perpignan, 66046
Research Site
Pessac, 33604
Research Site
Poitiers, 86000
Research Site
Reims, 51092
Research Site
Rennes, 35033
Research Site
Saint-Priest-en-Jarez, 42270
Research Site
Strasbourg, 67091
Research Site
Toulouse, 31059
Research Site
Vandœuvre-lès-Nancy, 54511
Research Site
Vesoul, 70014
South Africa28 sites
Research Site
Alberton, Gauteng, 1449
Research Site
Alberton, Gauteng, 1450
Research Site
Bloemfontein, Free State, 9301
Research Site
Boksburg, Gauteng, 1459
Research Site
Cape Town, 7405
Research Site
Cape Town, 7530
Research Site
Centurion, Gauteng, 0157
Research Site
Durban, KwaZulu-Natal, 4001
Research Site
Durban, KwaZulu-Natal, 4321
Research Site
eManzimtoti, KwaZulu-Natal, 4126
Research Site
Johannesburg, Gauteng, 1724
Research Site
Johannesburg, Gauteng, 2196
Research Site
Kempton Park, 1619
Research Site
Kuils River, Western Cape, 7580
Research Site
Midrand, Gauteng, 1685
Research Site
Paarl, Western Cape, 7646
Research Site
Parow, Western Cape, 7505
Research Site
Port Elizabeth, Eastern Cape, 6001
Research Site
Pretoria, Gauteng, 0040
Research Site
Pretoria, Gauteng, 0087
Research Site
Pretoria, Gauteng, 0158
Research Site
Pretoria, Gauteng, 0184
Research Site
Pretoria West, Gauteng, 0183
Research Site
Somerset West, Western Cape, 7130
Research Site
Soweto, Gauteng, 2013
Research Site
Sunninghill, Gauteng, 2157
Research Site
Tongaat, KwaZulu-Natal, 4400
Research Site
Worcester, Western Cape, 6850
Brazil26 sites
Research Site
Belo Horizonte, Minas Gerais, 30150-240
Research Site
Brasília, Federal District, 71625-009
Research Site
Campina Grande do Sul, Paraná, 83430-000
Research Site
Campinas, São Paulo, 13010-001
Research Site
Campinas, São Paulo, 13059-740
Research Site
Canoas, Rio Grande do Sul, 92425-900
Research Site
Curitiba, Paraná, 80010-030
Research Site
Curitiba, Paraná, 80730-150
Research Site
Fortaleza, Ceará, 60430-350
Research Site
Goiânia, Goiás, 74223-130
Research Site
Passo Fundo, Rio Grande do Sul, 99010-080
Research Site
Porto Alegre, Rio Grande do Sul, 90020-090
Research Site
Porto Alegre, Rio Grande do Sul, 90035-001
Research Site
Porto Alegre, Rio Grande do Sul, 90035-903
Research Site
Porto Alegre, Rio Grande do Sul, 90610-000
Research Site
Porto Alegre, Rio Grande do Sul, 90620-001
Research Site
Porto Alegre, Rio Grande do Sul, 90880-480
Research Site
Porto Alegre, Rio Grande do Sul, 91350-200
Research Site
Rio de Janeiro, 22271-100
Research Site
São José do Rio Preto, São Paulo, 15015-210
Research Site
São Paulo, São Paulo, 01244-030
Research Site
São Paulo, São Paulo, 04004-030
Research Site
São Paulo, 04040-000
Research Site
São Paulo, 04266-010
Research Site
São Paulo, 05403-000
Research Site
Vitória, Espírito Santo, 29042-751
Hungary24 sites
Research Site
Balatonfüred, 8230
Research Site
Békéscsaba, 5600
Research Site
Berettyóújfalu, 4100
Research Site
Budapest, 1027
Research Site
Budapest, 1036
Research Site
Budapest, 1085
Research Site
Budapest, 1096
Research Site
Budapest, 1122
Research Site
Budapest, 1125
Research Site
Budapest, 1134
Research Site
Cegléd, 2700
Research Site
Debrecen, 4032
Research Site
Gyöngyös, 3200
Research Site
Gyula, 5700
Research Site
Kaposvár, 7400
Research Site
Kecskemét, 6000
Research Site
Komárom, 2921
Research Site
Miskolc, 3529
Research Site
Nyíregyháza, 4400
Research Site
Pécs, 7624
Research Site
Szeged, 6725
Research Site
Szekszárd, 7100
Research Site
Szolnok, 5004
Research Site
Zalaegerszeg, 8900
Argentina23 sites
Research Site
Bahía Blanca, Buenos Aires, B8000FTD
Research Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, 1209
Research Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1093AAS
Research Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1128AAF
Research Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1426EGR
Research Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1428AQK
Research Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1430CKE
Research Site
Córdoba, Córdoba Province, X5000BNB
Research Site
Córdoba, Córdoba Province, X5000EPU
Research Site
Córdoba, Córdoba Province, X5002AOQ
Research Site
Córdoba, Córdoba Province, X5016KEH
Research Site
Córdoba, X5003DCE
Research Site
Corrientes, W3400AMZ
Research Site
La Plata, Buenos Aires, B1902AGY
Research Site
La Plata, Buenos Aires, B1902COS
Research Site
Mar del Plata, Buenos Aires, B7600FZN
Research Site
Mar del Plata, Buenos Aires, B7602CBM
Research Site
Quilmes, Buenos Aires, B1878GEG
Research Site
Rosario, Santa Fe Province, S2000CVD
Research Site
Salta, A4400ANG
Research Site
Salta, A4400CRC
Research Site
San Miguel de Tucumán, Tucumán Province, T4000IAF
Research Site
San Miguel de Tucumán, Tucumán Province, T4000ICL
Ukraine22 sites
Research Site
Cherkasy, 18009
Research Site
Ivano-Frankivsk, 76018
Research Site
Kharkiv, 61002
Research Site
Kharkiv, 61018
Research Site
Kharkiv, 61039
Research Site
Kharkiv, 61106
Research Site
Kharkiv, 61176
Research Site
Kyiv, 01023
Research Site
Kyiv, 02002
Research Site
Kyiv, 02091
Research Site
Kyiv, 02232
Research Site
Kyiv, 02660
Research Site
Kyiv, 03049
Research Site
Kyiv, 03680
Research Site
Kyiv, 04114
Research Site
Luhansk, 91045
Research Site
Uzhhorod, 88000
Research Site
Vinnytsia, 21018
Research Site
Vinnytsia, 21029
Research Site
Zaporizhzhya, 69000
Research Site
Zaporizhzhya, 69035
Research Site
Zaporizhzhya, 69600
Australia21 sites
Research Site
Adelaide, South Australia, 5000
Research Site
Ashford, South Australia, 5035
Research Site
Ashford, South Australia, 5036
Research Site
Auchenflower, Queensland, 4066
Research Site
Box Hill, Victoria, 3128
Research Site
Camperdown, New South Wales, 2050
Research Site
Concord, New South Wales, 2139
Research Site
Epping, Victoria, 3076
Research Site
Footscray, Victoria, 3011
Research Site
Fullarton, South Australia, 5063
Research Site
Geelong, Victoria, 3220
Research Site
Heidelberg, Victoria, 3084
Research Site
Herston, Queensland, 4029
Research Site
Hobart, Tasmania, 7000
Research Site
Kogarah, New South Wales, 2217
Research Site
Liverpool, New South Wales, 2170
Research Site
Nedlands, Western Australia, 6009
Research Site
Woden, Australian Capital Territory, 2605
Research Site
Woodville South, South Australia, 5011
Research Site
Woolloongabba, New South Wales, 4102
Research Site
Woolloongabba, Queensland, 4102
Slovakia21 sites
Research Site
Bánovce nad Bebravou, 957 01
Research Site
Bardejov, 085 01
Research Site
Bratislava, 811 04
Research Site
Bratislava, 811 08
Research Site
Bratislava, 833 48
Research Site
Brezno, 977 42
Research Site
Dolný Kubín, 026 01
Research Site
Košice, 040 01
Research Site
Košice, 040 22
Research Site
Lučenec, 984 01
Research Site
Martin, 036 59
Research Site
Moldava nad Bodvou, 045 01
Research Site
Nitra, 949 01
Research Site
Nové Zámky, 940 01
Research Site
Prešov, 080 01
Research Site
Rimavská Sobota, 979 01
Research Site
Rožňava, 048 01
Research Site
Snina, 069 01
Research Site
Svidník, 089 01
Research Site
Trenčín, 911 01
Research Site
Trnava, 917 01
Italy20 sites
Research Site
Ascoli Piceno, 63100
Research Site
Bergamo, 24127
Research Site
Bologna, 40138
Research Site
Chieti, 66100
Research Site
Colleferro RM, 00034
Research Site
Cortona AR, 52044
Research Site
Florence, 50139
Research Site
L’Aquila, 67100
Research Site
Milan, 20138
Research Site
Milan, 20162
Research Site
Naples, 80131
Research Site
Palermo, 90126
Research Site
Parma, 43100
Research Site
Pavia, 27100
Research Site
Perugia, 06129
Research Site
Pisa, 56124
Research Site
Roma, 00161
Research Site
Roma, 00168
Research Site
Sanremo (IM), 18038
Research Site
Siena, 53100
Greece19 sites
Research Site
Alexandroupoli, 68100
Research Site
Athens, 10676
Research Site
Athens, 11521
Research Site
Athens, 11527
Research Site
Athens, 12462
Research Site
Athens, 14233
Research Site
Athens, 14561
Research Site
Athens, 15123
Research Site
Athens, 16673
Research Site
Athens, 17674
Research Site
Chalcis, 34100
Research Site
Heraklion, 71110
Research Site
Ioannina, 45500
Research Site
Larissa, 41110
Research Site
Nikaia, Piraeus, 18454
Research Site
Piraeus, 18536
Research Site
Rhodes, 85100
Research Site
Thessaloniki, 54636
Research Site
Thessaloniki, 54642
India19 sites
Research Site
Ahmedabad, Gujarat, 380 008
Research Site
Ahmedabad, Gujarat, 380 016
Research Site
Ahmedabad, Gujarat, 380 054
Research Site
Ahmedabad, Gujarat, 380 060
Research Site
Belagavi, Karnataka, 590 010
Research Site
Gurgaon, Haryana, 122 001
Research Site
Kolkata, West Bengal, 700 020
Research Site
Lucknow, Uttar Pradesh, 226 003
Research Site
Mumbai, Maharashtra, 400 007
Research Site
Mumbai, Maharashtra, 400 008
Research Site
Mumbai, Maharashtra, 400 022
Research Site
Mysore, Karnataka, 570 001
Research Site
Nagpur, Maharashtra, 440 003
Research Site
New Delhi, National Capital Territory of Delhi, 110 002
Research Site
Pune, Maharashtra, 411 005
Research Site
Pune, Maharashtra, 411 006
Research Site
Pune, Maharashtra, 411 019
Research Site
Vadodara, Gujarat, 390 001
Research Site
Vijayawada, Andhra Pradesh, 520 008
Sweden19 sites
Research Site
Bollnäs, 821 81
Research Site
Eksjö, 575 81
Research Site
Eskilstuna, 631 88
Research Site
Falun, 791 82
Research Site
Helsingborg, 251 87
Research Site
Jönköping, 551 85
Research Site
Linköping, 581 85
Research Site
Luleå, 971 80
Research Site
Lund, 221 85
Research Site
Lund, 222 21
Research Site
Örebro, 701 85
Research Site
Östersund, 831 83
Research Site
Stockholm, 111 57
Research Site
Stockholm, 118 83
Research Site
Stockholm, 141 86
Research Site
Stockholm, 171 76
Research Site
Uddevalla, 451 50
Research Site
Umeå, 901 85
Research Site
Västerås, 721 89
Mexico17 sites
Research Site
Aguascalientes, 20230
Research Site
Chihuahua City, 31217
Research Site
Culiacán, Sinaloa, 80230
Research Site
Guadalajara, Jalisco, 44150
Research Site
Guadalajara, Jalisco, 44210
Research Site
Guadalajara, Jalisco, 44340
Research Site
Guadalajara, Jalisco, 44380
Research Site
Guadalajara, Jalisco, 44600
Research Site
León, Guanajuato, 37520
Research Site
Mexico City, Mexico City, 03800
Research Site
Mexico City, Mexico City, 14380
Research Site
Monterrey, Nuevo León, 64718
Research Site
Querétaro City, Querétaro, 76000
Research Site
San Luis Potosí City, San Luis Potosí, 78240
Research Site
Tampico, Tamaulipas, 89000
Research Site
Torreón, Coahuila, 27000
Research Site
Xalapa, Veracruz, 91193
South Korea17 sites
Research Site
Busan, Seo-gu, 602-715
Research Site
Daejeon, 301-723
Research Site
Daejeon, 371-718
Research Site
Goyang-si, Gyeonggi-do, 411-706
Research Site
Gwangju, 501-757
Research Site
Seongnam-si, 463-707
Research Site
Seoul, 110-746
Research Site
Seoul, 120-752
Research Site
Seoul, 130-872
Research Site
Seoul, 135-700
Research Site
Seoul, 135-710
Research Site
Seoul, 137-701
Research Site
Seoul, 138-736
Research Site
Seoul, 152-703
Research Site
Seoul, 156-707
Research Site
Seoul, 158-710
Research Site
Suwon, 443-380
Belgium16 sites
Research Site
Aalst, 9300
Research Site
Antwerp, 2020
Research Site
Antwerp, 2060
Research Site
Blankenberge, 8370
Research Site
Bonheiden, 2820
Research Site
Brussels, 1020
Research Site
Brussels, 1070
Research Site
Brussels, 1200
Research Site
Ghent, 9000
Research Site
Gozée, 6534
Research Site
Ieper, 8900
Research Site
La Louvière, 7100
Research Site
Liège, 4000
Research Site
Lodelinsart, 6042
Research Site
Natoye, 5360
Research Site
Turnhout, 2300
Romania16 sites
Research Site
Bucharest, 010242
Research Site
Bucharest, 011601
Research Site
Bucharest, 020054
Research Site
Bucharest, 020125
Research Site
Bucharest, 021659
Research Site
Bucharest, 030463
Research Site
Bucharest, 042122
Research Site
Cluj-Napoca, 400347
Research Site
Craiova, 200147
Research Site
Iași, 700503
Research Site
Iași, 700547
Research Site
Iași, 700661
Research Site
Oradea, 410169
Research Site
Timișoara, 300079
Research Site
Timișoara, 300158
Research Site
Timișoara, 300736
Denmark14 sites
Research Site
Aalborg, 9000
Research Site
Aarhus N, 8200
Research Site
Ballerup Municipality, 2750
Research Site
Copenhagen, 2400
Research Site
Esbjerg, 6700
Research Site
Glostrup Municipality, 2600
Research Site
Hvidovre, 2650
Research Site
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About this study
Official title: A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Additional LDL-Cholesterol Reduction on Major Cardiovascular Events When Evolocumab (AMG 145) is Used in Combination With Statin Therapy In Patients With Clinically Evident Cardiovascular Disease
The primary objective was to evaluate the effect of treatment with evolocumab, compared with placebo, on the risk for cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization, whichever occurs first, in patients with clinically evident cardiovascular disease.
- Conditions
- Dyslipidemia
- Being tested
- Evolocumab, Placebo
- Keywords
- High cholesterol, Treatment for high cholesterol, Lowering cholesterol, Lowering high cholesterol, Hypercholesterolemia
- Medical subject headings
- Dyslipidemias, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvolocumabBiological
Also called AMG 145, Repatha
Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen.
PlaceboDrug
Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference. Receives: Drug: Placebo |
| Evolocumab | Experimental | Participants received evolocumab 140 mg Q2W or 420 mg QM subcutaneous injections according to their own preference. Receives: Biological: Evolocumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Cardiovascular Death, Myocardial Infarction, Hospitalization for Unstable Angina, Stroke, or Coronary Revascularization
All deaths and potential endpoint events were adjudicated by an independent external Clinical Events Committee (CEC) led by the Thrombolysis in Myocardial Infarction (TIMI) Study Group, using standardized definitions based on the "Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials and the Third Universal Definition of Myocardial Infarction".
Time to cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization was defined as the time from randomization to the first occurrence of any component of the composite endpoint and was analyzed using Kaplan-Meier (KM) survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on last non-fatal potential endpoint collection date.
Measured: Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.
Secondary outcomes (8)
Time to Cardiovascular Death, Myocardial Infarction, or Stroke
All deaths and potential endpoint events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions based on the "Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials and the Third Universal Definition of Myocardial Infarction". Time to cardiovascular death, myocardial infarction, or stroke was defined as the time from randomization to the first occurrence of any component of the composite endpoint and was analyzed using Kaplan-Meier (KM) survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on last non-fatal potential endpoint collection date.
Measured: Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.
Time to Cardiovascular Death
All deaths and potential endpoint events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions based on the "Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials and the Third Universal Definition of Myocardial Infarction".
Cardiovascular death includes death resulting from an acute myocardial infarction (MI), sudden cardiac death, death due to heart failure (HF), death due to stroke, death due to cardiovascular (CV) procedures, death due to CV hemorrhage, and death due to other CV causes.
Time to cardiovascular death was defined as the time from randomization to the date of cardiovascular death and was analyzed using Kaplan-Meier (KM) survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on the last confirmed survival status date.
Measured: Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.
Time to All Cause Death
Time to all-cause death was defined as the time from randomization to the date of death and was analyzed using Kaplan-Meier (KM) survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on the last confirmed survival status date.
Measured: Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.
Time to First Myocardial Infarction
All deaths and potential endpoint events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions based on the "Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials and the Third Universal Definition of Myocardial Infarction".
The diagnosis of myocardial infarction required the combination of:
- Evidence of myocardial necrosis (either changes in cardiac biomarkers or post-mortem pathological findings); and
- Supporting information derived from the clinical presentation, electrocardiographic changes, or the results of myocardial or coronary artery Imaging.
Time to first myocardial infarction was defined as the time from randomization to the date of the first MI and was analyzed using Kaplan-Meier survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on last non-fatal potential endpoint collection date.
Measured: Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.
Time to First Stroke
All deaths and potential endpoint events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions based on the "Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials and the Third Universal Definition of Myocardial Infarction".
Stroke was defined as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of hemorrhage or infarction.
Time to first stroke was defined as the time from randomization to the date of the stroke and was analyzed using Kaplan-Meier (KM) survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on last non-fatal potential endpoint collection date.
Measured: Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.
Time to First Coronary Revascularization
All deaths and potential endpoint events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions based on the "Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials and the Third Universal Definition of Myocardial Infarction".
Time to first coronary revascularization was defined as the time from randomization to the date of the coronary revascularization and was analyzed using Kaplan-Meier (KM) survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on last non-fatal potential endpoint collection date.
Measured: Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.
Time to Cardiovascular Death or First Hospitalization for Worsening Heart Failure
All events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions.
HF hospitalization was defined as an event that met all of the following criteria:
- Admitted to hospital with a primary diagnosis of HF
- In hospital for at least 24 hours
- Documented new or worsening symptoms due to HF, including at least 1 of the following:
- Dyspnea
- Decreased exercise tolerance
- Fatigue
- Other symptoms of worsened end-organ perfusion or volume overload
- Evidence of new or worsening HF consisting of at least 2 physical exam findings or 1 physical exam finding and at least 1 laboratory criterion
- Received new or increased treatment for HF. Time to CV death or first hospitalization for worsening HF was defined as the time from randomization to the first occurrence of any component of the endpoint analyzed using KM survival analysis. Participants with no event were censored based on last non-fatal potential endpoint collection date.
Measured: Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.
Time to First Ischemic Fatal or Non-Fatal Stroke or Transient Ischemic Attack
All deaths and potential endpoint events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions.
Ischemic stroke was defined as an acute episode of focal cerebral, spinal, or retinal dysfunction caused by infarction of central nervous system tissue. Transient ischemic attack (TIA) was defined as a transient episode of focal neurological dysfunction caused by brain, spinal cord, or retinal ischemia, without acute infarction.
Time to first ischemic fatal or non-fatal stroke or TIA was defined as the time from randomization to the first occurrence of any component of the composite endpoint and was analyzed using KM analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on last non-fatal potential endpoint collection date.
Measured: Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2013 (estimated)
- Study start8 Feb 2013
- Primary completion11 Nov 2016
- Study completion11 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 27,564 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01764633
- Sponsor's protocol ID
- 20110118
- Other IDs
- 2014/01/004324, 2012-001398-97
- Acronym
- FOURIER
- Status last verified
- May 2024
- First submitted
- 8 Jan 2013
- Last updated
- 28 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Sabatine MS, Giugliano RP, Keech AC, Honarpour N, Wiviott SD, Murphy SA, Kuder JF, Wang H, Liu T, Wasserman SM, Sever PS, Pedersen TR; FOURIER Steering Committee and Investigators. Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease. N Engl J Med. 2017 May 4;376(18):1713-1722. doi: 10.1056/NEJMoa1615664. Epub 2017 Mar 17.
PubMed 28304224Fonarow GC, Keech AC, Pedersen TR, Giugliano RP, Sever PS, Lindgren P, van Hout B, Villa G, Qian Y, Somaratne R, Sabatine MS. Cost-effectiveness of Evolocumab Therapy for Reducing Cardiovascular Events in Patients With Atherosclerotic Cardiovascular Disease. JAMA Cardiol. 2017 Oct 1;2(10):1069-1078. doi: 10.1001/jamacardio.2017.2762.
PubMed 28832867Fonarow GC, van Hout B, Villa G, Arellano J, Lindgren P. Updated Cost-effectiveness Analysis of Evolocumab in Patients With Very High-risk Atherosclerotic Cardiovascular Disease. JAMA Cardiol. 2019 Jul 1;4(7):691-695. doi: 10.1001/jamacardio.2019.1647.
PubMed 31166576Schludi B, Giugliano RP, Sabatine MS, Raal FJ, Teramoto T, Koren MJ, Stein EA, Wang H, Monsalvo ML. Time-averaged low-density lipoprotein cholesterol lowering with evolocumab: Pooled analysis of phase 2 trials. J Clin Lipidol. 2022 Jul-Aug;16(4):538-543. doi: 10.1016/j.jacl.2022.05.069. Epub 2022 Jun 6.
PubMed 35760720Berg DD, Moura FA, Bellavia A, Scirica BM, Wiviott SD, Bhatt DL, Raz I, Bohula EA, Giugliano RP, Park JG, Feinberg MW, Braunwald E, Morrow DA, Sabatine MS. Assessment of Atherothrombotic Risk in Patients With Type 2 Diabetes Mellitus. J Am Coll Cardiol. 2023 Jun 27;81(25):2391-2402. doi: 10.1016/j.jacc.2023.04.031.
PubMed 37344040Clinical Benefit of Evolocumab Treatment Among Patients With Atherosclerotic Cardiovascular Disease: Exploration Based on the Chinese Subgroup of FOURIER Study, ZHANG Lihua1 , LI Weimin2 , YAO Zhuhua3 , CHEN Jiyan4 , DONG Jun5 , LI Jing1 (Chinese Circulation Journal, 2023, 38: 704.)
Monguillon V, Kelly PJ, O'Donoghue ML, Park JG, Bohula EA, Saver JL, Atar D, Keech AC, Sever PS, Wang H, Paiva da Silva Lima G, Sabatine MS, Giugliano RP. Efficacy and Safety of Very Low Achieved LDL Cholesterol in Patients With Previous Ischemic Stroke. Circulation. 2026 Jan 13;153(2):86-93. doi: 10.1161/CIRCULATIONAHA.125.077549. Epub 2025 Nov 3.
PubMed 41178569Zimerman A, Kunzler ALF, Weber BN, Ran X, Murphy SA, Wang H, Honarpour N, Keech AC, Sever PS, Sabatine MS, Giugliano RP. Intensive Lowering of LDL Cholesterol Levels With Evolocumab in Autoimmune or Inflammatory Diseases: An Analysis of the FOURIER Trial. Circulation. 2025 May 20;151(20):1467-1476. doi: 10.1161/CIRCULATIONAHA.124.072756. Epub 2025 Apr 21.
PubMed 40255182Gaba P, O'Donoghue ML, Park JG, Wiviott SD, Atar D, Kuder JF, Im K, Murphy SA, De Ferrari GM, Gaciong ZA, Toth K, Gouni-Berthold I, Lopez-Miranda J, Schiele F, Mach F, Flores-Arredondo JH, Lopez JAG, Elliott-Davey M, Wang B, Monsalvo ML, Abbasi S, Giugliano RP, Sabatine MS. Association Between Achieved Low-Density Lipoprotein Cholesterol Levels and Long-Term Cardiovascular and Safety Outcomes: An Analysis of FOURIER-OLE. Circulation. 2023 Apr 18;147(16):1192-1203. doi: 10.1161/CIRCULATIONAHA.122.063399. Epub 2023 Feb 13.
PubMed 36779348Erviti J, Wright J, Bassett K, Ben-Eltriki M, Jauca C, Saiz LC, Leache L, Gutierrez-Valencia M, Perry TL. Restoring mortality data in the FOURIER cardiovascular outcomes trial of evolocumab in patients with cardiovascular disease: a reanalysis based on regulatory data. BMJ Open. 2022 Dec 30;12(12):e060172. doi: 10.1136/bmjopen-2021-060172.
PubMed 36585131Fagundes A Jr, Morrow DA, Oyama K, Furtado RHM, Zelniker TA, Tang M, Kuder JF, Murphy SA, Hamer A, Keech AC, Sever P, Giugliano RP, Sabatine MS, Bergmark BA. Biomarker Prediction of Complex Coronary Revascularization Procedures in the FOURIER Trial. J Am Coll Cardiol. 2022 Aug 30;80(9):887-897. doi: 10.1016/j.jacc.2022.05.051.
PubMed 36007987Furtado RHM, Fagundes AA Jr, Oyama K, Zelniker TA, Tang M, Kuder JF, Murphy SA, Hamer A, Wang H, Keech AC, Giugliano RP, Sabatine MS, Bergmark BA. Effect of Evolocumab in Patients With Prior Percutaneous Coronary Intervention. Circ Cardiovasc Interv. 2022 Mar;15(3):e011382. doi: 10.1161/CIRCINTERVENTIONS.121.011382. Epub 2022 Feb 25.
PubMed 35209731Oyama K, Giugliano RP, Tang M, Bonaca MP, Saver JL, Murphy SA, Ruzza A, Keech AC, Sever PS, Sabatine MS, Bergmark BA. Effect of evolocumab on acute arterial events across all vascular territories : results from the FOURIER trial. Eur Heart J. 2021 Dec 14;42(47):4821-4829. doi: 10.1093/eurheartj/ehab604.
PubMed 34537830Keech AC, Oyama K, Sever PS, Tang M, Murphy SA, Hirayama A, Lu C, Tay L, Deedwania PC, Siu CW, Lira Pineda A, Choi D, Charng MJ, Amerena J, Wan Ahmad WA, Chopra VK, Pedersen TR, Giugliano RP, Sabatine MS; FOURIER Study Group. Efficacy and Safety of Long-Term Evolocumab Use Among Asian Subjects - A Subgroup Analysis of the Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk (FOURIER) Trial. Circ J. 2021 Oct 25;85(11):2063-2070. doi: 10.1253/circj.CJ-20-1051. Epub 2021 May 15.
PubMed 33980763Oyama K, Furtado RHM, Fagundes A Jr, Zelniker TA, Tang M, Kuder J, Murphy SA, Hamer A, Wang H, Keech AC, Giugliano RP, Sabatine MS, Bergmark BA. Effect of Evolocumab on Complex Coronary Disease Requiring Revascularization. J Am Coll Cardiol. 2021 Jan 26;77(3):259-267. doi: 10.1016/j.jacc.2020.11.011. Epub 2020 Nov 13.
PubMed 33197560
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Additional LDL-Cholesterol Reduction on Major Cardiovascular Events When Evolocumab (AMG 145) is Used in Combination With Statin Therapy In Patients With Clinically Evident Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT01764633
- Acronym / sponsor ID
- FOURIER / 20110118
- Conditions
- Dyslipidemia
- Keywords
- High cholesterol, Treatment for high cholesterol, Lowering cholesterol, Lowering high cholesterol, Hypercholesterolemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27,564 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 8 Feb 2013 (actual)
- Primary completion
- 11 Nov 2016 (actual)
- Study completion
- 11 Nov 2016 (actual)
- First posted
- 9 Jan 2013 (estimated)
- Results
- Posted 15 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective was to evaluate the effect of treatment with evolocumab, compared with placebo, on the risk for cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization, whichever occurs first, in patients with clinically evident cardiovascular disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboParticipants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference. |
| Evolocumab | Experimental | Biological: EvolocumabParticipants received evolocumab 140 mg Q2W or 420 mg QM subcutaneous injections according to their own preference. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female ≥ 40 to ≤ 85 years of age
- History of clinically evident cardiovascular disease at high risk for a recurrent event
- Fasting low-density lipoprotein cholesterol (LDL-C) ≥ 70 mg/dL (≥ 1.8 mmol/L) ) or non-high-density lipoprotein cholesterol (non-HDL-C) ≥ 100 mg/dL (> 2.6 mmol/L)
- Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L)
Key exclusion criteria (6 listed)
- New York Heart Association (NYHA) class III or IV, or last known left ventricular ejection fraction < 30%
- Uncontrolled hypertension
- Uncontrolled or recurrent ventricular tachycardia
- Untreated hyperthyroidism or hypothyroidism
- Homozygous familial hypercholesterolemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EvolocumabAlso: AMG 145, RepathaAdministered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen. | Biological | Evolocumab |
| PlaceboAdministered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen. | Drug | Placebo |
Primary outcome
Time to Cardiovascular Death, Myocardial Infarction, Hospitalization for Unstable Angina, Stroke, or Coronary Revascularization
Time frame: Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.
All deaths and potential endpoint events were adjudicated by an independent external Clinical Events Committee (CEC) led by the Thrombolysis in Myocardial Infarction (TIMI) Study Group, using standardized definitions based on the "Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials and the Third Universal Definition of Myocardial Infarction". Time to cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization was defined as the time from randomization to the first occurrence of any component of the composite endpoint and was analyzed using Kaplan-Meier (KM) survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on last non-fatal potential endpoint collection date.
8 secondary outcomes
Time to Cardiovascular Death, Myocardial Infarction, or Stroke
Time frame: Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.
Time to Cardiovascular Death
Time frame: Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.
Time to All Cause Death
Time frame: Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.
Time to First Myocardial Infarction
Time frame: Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.
Time to First Stroke
Time frame: Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.
Time to First Coronary Revascularization
Time frame: Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.
Time to Cardiovascular Death or First Hospitalization for Worsening Heart Failure
Time frame: Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.
Time to First Ischemic Fatal or Non-Fatal Stroke or Transient Ischemic Attack
Time frame: Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28304224Sabatine MS, Giugliano RP, Keech AC, Honarpour N, Wiviott SD, Murphy SA, Kuder JF, Wang H, Liu T, Wasserman SM, Sever PS, Pedersen TR; FOURIER Steering Committee and Investigators. Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease. N Engl J Med. 2017 May 4;376(18):1713-1722. doi: 10.1056/NEJMoa1615664. Epub 2017 Mar 17.
- Background: PubMed 28832867Fonarow GC, Keech AC, Pedersen TR, Giugliano RP, Sever PS, Lindgren P, van Hout B, Villa G, Qian Y, Somaratne R, Sabatine MS. Cost-effectiveness of Evolocumab Therapy for Reducing Cardiovascular Events in Patients With Atherosclerotic Cardiovascular Disease. JAMA Cardiol. 2017 Oct 1;2(10):1069-1078. doi: 10.1001/jamacardio.2017.2762.
- Background: PubMed 31166576Fonarow GC, van Hout B, Villa G, Arellano J, Lindgren P. Updated Cost-effectiveness Analysis of Evolocumab in Patients With Very High-risk Atherosclerotic Cardiovascular Disease. JAMA Cardiol. 2019 Jul 1;4(7):691-695. doi: 10.1001/jamacardio.2019.1647.
- Background: PubMed 35760720Schludi B, Giugliano RP, Sabatine MS, Raal FJ, Teramoto T, Koren MJ, Stein EA, Wang H, Monsalvo ML. Time-averaged low-density lipoprotein cholesterol lowering with evolocumab: Pooled analysis of phase 2 trials. J Clin Lipidol. 2022 Jul-Aug;16(4):538-543. doi: 10.1016/j.jacl.2022.05.069. Epub 2022 Jun 6.
- Background: PubMed 37344040Berg DD, Moura FA, Bellavia A, Scirica BM, Wiviott SD, Bhatt DL, Raz I, Bohula EA, Giugliano RP, Park JG, Feinberg MW, Braunwald E, Morrow DA, Sabatine MS. Assessment of Atherothrombotic Risk in Patients With Type 2 Diabetes Mellitus. J Am Coll Cardiol. 2023 Jun 27;81(25):2391-2402. doi: 10.1016/j.jacc.2023.04.031.
- BackgroundClinical Benefit of Evolocumab Treatment Among Patients With Atherosclerotic Cardiovascular Disease: Exploration Based on the Chinese Subgroup of FOURIER Study, ZHANG Lihua1 , LI Weimin2 , YAO Zhuhua3 , CHEN Jiyan4 , DONG Jun5 , LI Jing1 (Chinese Circulation Journal, 2023, 38: 704.)
- Derived from this study: PubMed 41178569Monguillon V, Kelly PJ, O'Donoghue ML, Park JG, Bohula EA, Saver JL, Atar D, Keech AC, Sever PS, Wang H, Paiva da Silva Lima G, Sabatine MS, Giugliano RP. Efficacy and Safety of Very Low Achieved LDL Cholesterol in Patients With Previous Ischemic Stroke. Circulation. 2026 Jan 13;153(2):86-93. doi: 10.1161/CIRCULATIONAHA.125.077549. Epub 2025 Nov 3.
- Derived from this study: PubMed 40255182Zimerman A, Kunzler ALF, Weber BN, Ran X, Murphy SA, Wang H, Honarpour N, Keech AC, Sever PS, Sabatine MS, Giugliano RP. Intensive Lowering of LDL Cholesterol Levels With Evolocumab in Autoimmune or Inflammatory Diseases: An Analysis of the FOURIER Trial. Circulation. 2025 May 20;151(20):1467-1476. doi: 10.1161/CIRCULATIONAHA.124.072756. Epub 2025 Apr 21.
- Derived from this study: PubMed 36779348Gaba P, O'Donoghue ML, Park JG, Wiviott SD, Atar D, Kuder JF, Im K, Murphy SA, De Ferrari GM, Gaciong ZA, Toth K, Gouni-Berthold I, Lopez-Miranda J, Schiele F, Mach F, Flores-Arredondo JH, Lopez JAG, Elliott-Davey M, Wang B, Monsalvo ML, Abbasi S, Giugliano RP, Sabatine MS. Association Between Achieved Low-Density Lipoprotein Cholesterol Levels and Long-Term Cardiovascular and Safety Outcomes: An Analysis of FOURIER-OLE. Circulation. 2023 Apr 18;147(16):1192-1203. doi: 10.1161/CIRCULATIONAHA.122.063399. Epub 2023 Feb 13.
- Derived from this study: PubMed 36585131Erviti J, Wright J, Bassett K, Ben-Eltriki M, Jauca C, Saiz LC, Leache L, Gutierrez-Valencia M, Perry TL. Restoring mortality data in the FOURIER cardiovascular outcomes trial of evolocumab in patients with cardiovascular disease: a reanalysis based on regulatory data. BMJ Open. 2022 Dec 30;12(12):e060172. doi: 10.1136/bmjopen-2021-060172.
- Derived from this study: PubMed 36007987Fagundes A Jr, Morrow DA, Oyama K, Furtado RHM, Zelniker TA, Tang M, Kuder JF, Murphy SA, Hamer A, Keech AC, Sever P, Giugliano RP, Sabatine MS, Bergmark BA. Biomarker Prediction of Complex Coronary Revascularization Procedures in the FOURIER Trial. J Am Coll Cardiol. 2022 Aug 30;80(9):887-897. doi: 10.1016/j.jacc.2022.05.051.
- Derived from this study: PubMed 35209731Furtado RHM, Fagundes AA Jr, Oyama K, Zelniker TA, Tang M, Kuder JF, Murphy SA, Hamer A, Wang H, Keech AC, Giugliano RP, Sabatine MS, Bergmark BA. Effect of Evolocumab in Patients With Prior Percutaneous Coronary Intervention. Circ Cardiovasc Interv. 2022 Mar;15(3):e011382. doi: 10.1161/CIRCINTERVENTIONS.121.011382. Epub 2022 Feb 25.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
1,284 sites in 49 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Evolocumab in people with Dyslipidemia, run by Amgen at 1,284 sites in 49 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1,284 sites in United States, United Kingdom, Japan, Poland, Czechia and 44 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Cardiovascular Death, Myocardial Infarction, Hospitalization for Unstable Angina, Stroke, or Coronary Revascularization (time frame: Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01764633, which also lists 31 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2024.