HypercholesterolemiaPhase 3GLAGOVNCT01813422
GLobal Assessment of Plaque reGression With a PCSK9 antibOdy as Measured by intraVascular Ultrasound
A Phase 3 study testing Evolocumab in people with Hypercholesterolemia, run by Amgen at 226 sites in 32 countries.
Trial summary
This study will evaluate whether low-density lipoprotein (LDL-C) lowering with evolocumab (AMG 145) results in greater change from baseline in percent atheroma volume (PAV) at week 78 than placebo in adults with coronary artery disease taking lipid lowering therapy. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hypercholesterolemia
- 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
- 970 participants
- Where
- 226 sitesin 32 countries
- Study dates
- 18 Apr 2013to 29 Jul 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical indication for coronary angiography
- Subjects already taking statin therapy, niacin or ezetimibe at screening must have been on a stable dose for at least 4 weeks prior to screening LDL-C. Subjects not taking lipid-regulating therapy must enter the study via a lipid stabilization period. Subjects who are intolerant to statins must meet statin intolerance entry criteria
- Fasting LDL-C ≥ 80 mg/dL (2.07 mmol/L) with or without additional risk factors, or, LDL-C ≥ 60 -< 80 mg/dL (1.55-2.07 mmol/L) in the presence of one major or three minor risk factors
- Subjects must meet the following criteria at the qualifying coronary catheterization procedure:
- Evidence of coronary heart disease (at least one lesion in a native coronary artery that has > 20% reduction in lumen diameter) or prior percutaneous intervention (PCI)
- Left main coronary artery < 50% reduction in lumen diameter by visual estimation
- Target coronary artery for IVUS must be accessible to the IVUS catheter, must not have a > 50% reduction in lumen diameter within the target segment (and at least 40 mm in length); cannot have undergone prior PCI or coronary artery bypass graft (CABG) and is not a candidate for intervention over the next 18 months. It may not be a bypass graft, bypassed vessel or culprit vessel for previous myocardial infarction (MI).
Who cannot join
- Coronary artery bypass graft surgery < 6 weeks prior to the qualifying IVUS
- New York Heart Association (NYHA) III or IV heart failure, or last known left ventricular ejection fraction less than 30%
- Uncontrolled cardiac arrhythmia that is not controlled by medications in the 3 months prior to randomization
- Known hemorrhagic stroke
- Uncontrolled hypertension at randomization
- Fasting Triglycerides ≥ 400 mg/dL (4.5 mmol/L) at screening
- Type 1 diabetes or poorly controlled type 2 diabetes (hemoglobin A1c [HbA1c] > 9%) at screening.
- Moderate to severe renal dysfunction (estimated glomerular filtration rate [eGFR] < 30 ml/min/1.73m²) at screening.
Trial locations and contacts
226 sites in 32 countries.
226 sites in 32 countries
United States59 sites
Research Site
Amarillo, Texas, 79106
Research Site
Ann Arbor, Michigan, 48109
Research Site
Atlanta, Georgia, 30342
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Atlantis, Florida, 33462
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Bay City, Michigan, 48708
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Bethesda, Maryland, 20814
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Buffalo, New York, 14215
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Canton, Ohio, 44710
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Charlotte, North Carolina, 28204
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Clearwater, Florida, 33756
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Columbia, Maryland, 21044
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Columbia, Missouri, 65212
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Covington, Louisiana, 70433
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Dallas, Texas, 75216
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Doylestown, Pennsylvania, 18901
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Duluth, Minnesota, 55805
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Elyria, Ohio, 44035
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Fargo, North Dakota, 58122
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Grand Rapids, Michigan, 49503
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Hammond, Indiana, 46320
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Hershey, Pennsylvania, 17033
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Hillsboro, Oregon, 97123
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Huntsville, Alabama, 35801
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Jacksonville, Florida, 32209
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Jacksonville, Florida, 32216
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Johnson City, New York, 13790
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La Jolla, California, 92037
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La Jolla, California, 92093-0960
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Lexington, Kentucky, 40536
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Little Rock, Arkansas, 72211
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Long Beach, California, 90822
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Louisville, Kentucky, 40205
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Marquette, Michigan, 49855
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Melbourne, Florida, 32901
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Midland, Michigan, 48670
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Minneapolis, Minnesota, 55407
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Missoula, Montana, 59802
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Mobile, Alabama, 36608
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Newport Beach, California, 92663
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Oak Ridge, Tennessee, 37830
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Oklahoma City, Oklahoma, 73104
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Omaha, Nebraska, 68198
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Orange, California, 92868
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Petoskey, Michigan, 49770
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Ridgewood, New Jersey, 07450
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Safety Harbor, Florida, 34695
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Saginaw, Michigan, 48601
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Saint Cloud, Minnesota, 56303
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Saint Paul, Minnesota, 55102
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San Antonio, Texas, 78229
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San Diego, California, 92161
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Santa Monica, California, 90404
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Springfield, Oregon, 97477
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Toledo, Ohio, 43614
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Torrance, California, 90502
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Tulsa, Oklahoma, 74104
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Valparaiso, Indiana, 46383
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Washington D.C., District of Columbia, 20010
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Wichita Falls, Texas, 76301
Canada16 sites
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Calgary, Alberta, T2N 4Z6
Research Site
Edmonton, Alberta, T5H 3V9
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Edmonton, Alberta, T6G 2B7
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Halifax, Nova Scotia, B3H 3A7
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Laval, Quebec, H7M 3L9
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London, Ontario, N6A 5A5
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Montreal, Quebec, H1T 2M4
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Montreal, Quebec, H3A 1A1
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Montreal, Quebec, H4J 1C5
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Québec, Quebec, G1V 4G5
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Saint John, New Brunswick, E2L 4L2
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St. John's, Newfoundland and Labrador, A1B 3V6
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Toronto, Ontario, M5B 1W8
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Toronto, Ontario, M5G 2C4
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Victoria, British Columbia, V8R 4R2
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Winnipeg, Manitoba, R2H 2A6
Australia13 sites
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Adelaide, South Australia, 5000
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Bedford Park, South Australia, 5042
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Chermside, Queensland, 4032
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Concord, New South Wales, 2139
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Darlinghurst, New South Wales, 2010
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Epping, Victoria, 3076
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Footscray, Victoria, 3011
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Heidelberg, Victoria, 3084
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Herston, Queensland, 4029
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Liverpool, New South Wales, 2170
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Melbourne, Victoria, 3004
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Nedlands, Western Australia, 6009
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New Lambton Heights, New South Wales, 2305
Netherlands12 sites
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Alkmaar, 1815 JD
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Amsterdam, 1081 HV
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Amsterdam, 1091 AC
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Eindhoven, 5623 EJ
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Leeuwarden, 8934 AD
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Nieuwegein, 3435 CM
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Nijmegen, 6532 SZ
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Rotterdam, 3079 DZ
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Tilburg, 5042 AD
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Utrecht, 3584 CX
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Venlo, 5912 BL
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Zwolle, 8025 AB
Argentina9 sites
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Buenos Aires, C1280AEB
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Ciudad Autonoma de Buenos Aires, Buenos Aires, C1199ABB
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Ciudad Autonoma de Buenos Aires, Buenos Aires, C1428DCO
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Córdoba, Córdoba Province, X5000JHQ
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Córdoba, Córdoba Province, X5016KEH
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Córdoba, X5003DCE
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Corrientes, W3400AMZ
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La Plata, Buenos Aires, 1900
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Rosario, Santa Fe Province, 2000
Belgium8 sites
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Antwerp, 2020
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Brussels, 1090
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Brussels, 1200
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Edegem, 2650
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Genk, 3600
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Ghent, 9000
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Hasselt, 3500
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Lodelinsart, 6042
Brazil8 sites
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Cariacica, Espírito Santo, 29156-580
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Curitiba, Paraná, 80320-320
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Goiânia, Goiás, 74223-130
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Porto Alegre, Rio Grande do Sul, 90020-090
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Porto Alegre, Rio Grande do Sul, 90610-000
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Porto Alegre, Rio Grande do Sul, 90620-001
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São Paulo, São Paulo, 04012-909
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São Paulo, 05403-000
Hungary7 sites
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Budapest, 1023
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Budapest, 1106
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Budapest, 1122
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Budapest, 1134
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Debrecen, 4032
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Pécs, 7624
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Szeged, 6725
Spain7 sites
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Barcelona, Catalonia, 08035
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Gijón, Principality of Asturias, 33394
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L'Hospitalet de Llobregat, Catalonia, 08907
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Madrid, 28034
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Madrid, 28046
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Málaga, Andalusia, 29010
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Santiago de Compostela, Galicia, 15706
Czechia6 sites
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Brno, 625 00
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Hradec Králové, 500 05
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Prague, 128 08
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Prague, 140 21
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Ústí nad Labem, 401 13
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Zlín, 762 75
France6 sites
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Besançon, 25030
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Chambray-lès-Tours, 37170
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Créteil, 94010
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Marseille, 13385
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Paris, 75015
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Pessac, 33604
Germany6 sites
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Aachen, 52074
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Essen, 45122
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München, 81737
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Neuss, 41464
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Regensburg, 93053
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Ulm, 89081
Mexico6 sites
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Aguascalientes, 20230
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Culiacán, Sinaloa, 80020
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Guadalajara, Jalisco, 44670
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Puebla City, 72490
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Querétaro City, Querétaro, 76000
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San Luis Potosí City, San Luis Potosí, 78240
Poland6 sites
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Chrzanów, 32-500
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Kędzierzyn-Koźle, 47-200
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Krakow, 31-202
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Krakow, 31-501
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Lodz, 90-549
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Warsaw, 04-628
South Africa6 sites
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Boksburg, Gauteng, 1470
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Centurion, Gauteng, 0157
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Johannesburg, Gauteng, 2157
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Kuils River, Western Cape, 7580
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Pinelands, Cape Town, Western Cape, 7405
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Somerset West, Western Cape, 7130
Sweden6 sites
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Gothenburg, 413 45
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Helsingborg, 251 87
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Lund, 221 85
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Örebro, 701 85
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Solna, 171 76
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Stockholm, 118 83
Greece5 sites
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Alexandroupoli, 68100
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Athens, 11527
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Athens, 14561
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Athens, 17674
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Heraklion, 71110
Italy5 sites
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Novara, 28100
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Roma, 00168
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Rozzano MI, 20089
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Sesto San Giovanni (MI), 20099
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Torino, 10154
Chile4 sites
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Santiago, 7650018
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Santiago, 8207257
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Santiago, 8330032
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Temuco, Cautín, 4781156
Russia4 sites
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Kemerovo, 650002
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Moscow, 101990
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Moscow, 119991
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Moscow, 121552
South Korea4 sites
Research Site
Daejeon, 301-723
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Seongnam-si, 463-707
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Seoul, 130-872
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Seoul, 156-707
Taiwan4 sites
Research Site
Kaohsiung City, 83301
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New Taipei City, 251
Research Site
Taichung, 402
Research Site
Taipei, 11217
Israel3 sites
Research Site
Hadera, 38100
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Jerusalem, 91031
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Rehovot, 76100
Philippines3 sites
Research Site
Pasig, 1600
Research Site
Quezon City, 1100
Research Site
Quezon City, 1102
Malaysia2 sites
Research Site
George Town, 10050
Research Site
Kuantan, Pahang, 25100
Switzerland2 sites
Research Site
Geneva, 1211
Research Site
Sankt Gallen, 9007
About this study
Official title: A Double-blind, Randomized, Multi-center, Placebo-controlled, Parallel-group Study to Determine the Effects of Evolocumab (AMG 145) Treatment on Atherosclerotic Disease Burden as Measured by Intravascular Ultrasound in Subjects Undergoing Coronary Catheterization
This study will evaluate whether low-density lipoprotein (LDL-C) lowering with evolocumab (AMG 145) results in greater change from baseline in percent atheroma volume (PAV) at week 78 than placebo in adults with coronary artery disease taking lipid lowering therapy.
- Conditions
- Hypercholesterolemia
- Being tested
- Evolocumab, Placebo
- Keywords
- Cholesterol, High Cholesterol, Elevated Cholesterol, Raised Cholesterol
- Medical subject headings
- 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 by subcutaneous injection
PlaceboDrug
Administered by subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants received placebo to evolocumab administered by subcutaneous injection once a month for 76 weeks. Receives: Drug: Placebo |
| Evolocumab | Experimental | Participants received 420 mg evolocumab administered by subcutaneous injection once a month for 76 weeks. Receives: Biological: Evolocumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Percent Atheroma Volume at Week 78
Intravascular ultrasound (IVUS) was used to visualize the extent of atherosclerotic plaques in the coronary artery lumen. The extent of atherosclerosis was expressed as percent atheroma volume (PAV) in a ≥ 40 mm segment of one targeted (imaged) coronary artery, calculated as the percentage of the total vessel volume occupied by atheroma.
Measured: Baseline and week 78
Secondary outcomes (3)
Change From Baseline in Total Atheroma Volume at Week 78
Intravascular ultrasound (IVUS) was used to visualize the extent of atherosclerotic plaques in the coronary artery lumen. Total atheroma volume (TAV) in a ≥ 40 mm segment of the targeted coronary artery was calculated as the average plaque area over the number of images that were evaluated by IVUS multiplied by the median vessel length to compensate for differences in segment length between participants.
Measured: Baseline and week 78
Percentage of Participants With Regression in Percent Atheroma Volume
Intravascular ultrasound (IVUS) was used to visualize the extent of atherosclerotic plaques in the coronary artery lumen. The extent of atherosclerosis was expressed as percent atheroma volume (PAV) in a ≥ 40 mm segment of one targeted (imaged) coronary artery, calculated as the percentage of the total vessel volume occupied by atheroma.
Regression in PAV was defined as any reduction from baseline in PAV.
Measured: Baseline and week 78
Percentage of Participants With Regression in Total Atheroma Volume
Intravascular ultrasound (IVUS) was used to visualize the extent of atherosclerotic plaques in the coronary artery lumen. Total atheroma volume (TAV) in a ≥ 40 mm segment of the targeted coronary artery was calculated as the average plaque area over the number of images that were evaluated by IVUS multiplied by the median vessel length to compensate for differences in segment length between participants.
Regression in TAV was defined as any reduction from baseline in TAV.
Measured: Baseline and week 78
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2013 (estimated)
- Study start18 Apr 2013
- Primary completion12 Jul 2016
- Study completion29 Jul 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 (4)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolemiaStudies 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
- 970 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
- NCT01813422
- Sponsor's protocol ID
- 20120153
- Other IDs
- 2012-004208-37
- Acronym
- GLAGOV
- Status last verified
- Feb 2019
- First submitted
- 15 Mar 2013
- Last updated
- 20 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Nicholls SJ, Puri R, Anderson T, Ballantyne CM, Cho L, Kastelein JJ, Koenig W, Somaratne R, Kassahun H, Yang J, Wasserman SM, Scott R, Ungi I, Podolec J, Ophuis AO, Cornel JH, Borgman M, Brennan DM, Nissen SE. Effect of Evolocumab on Progression of Coronary Disease in Statin-Treated Patients: The GLAGOV Randomized Clinical Trial. JAMA. 2016 Dec 13;316(22):2373-2384. doi: 10.1001/jama.2016.16951.
PubMed 27846344Nicholls SJ, Puri R, Anderson T, Ballantyne CM, Cho L, Kastelein JJP, Koenig W, Somaratne R, Kassahun H, Yang J, Wasserman SM, Honda S, Shishikura D, Scherer DJ, Borgman M, Brennan DM, Wolski K, Nissen SE. Effect of Evolocumab on Coronary Plaque Composition. J Am Coll Cardiol. 2018 Oct 23;72(17):2012-2021. doi: 10.1016/j.jacc.2018.06.078.
PubMed 30336824Schmidt AF, Carter JL, Pearce LS, Wilkins JT, Overington JP, Hingorani AD, Casas JP. PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2020 Oct 20;10(10):CD011748. doi: 10.1002/14651858.CD011748.pub3.
PubMed 33078867Puri R, Nissen SE, Somaratne R, Cho L, Kastelein JJ, Ballantyne CM, Koenig W, Anderson TJ, Yang J, Kassahun H, Wasserman SM, Scott R, Borgman M, Nicholls SJ. Impact of PCSK9 inhibition on coronary atheroma progression: Rationale and design of Global Assessment of Plaque Regression with a PCSK9 Antibody as Measured by Intravascular Ultrasound (GLAGOV). Am Heart J. 2016 Jun;176:83-92. doi: 10.1016/j.ahj.2016.01.019. Epub 2016 Feb 17.
PubMed 27264224
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Multi-center, Placebo-controlled, Parallel-group Study to Determine the Effects of Evolocumab (AMG 145) Treatment on Atherosclerotic Disease Burden as Measured by Intravascular Ultrasound in Subjects Undergoing Coronary Catheterization
- ClinicalTrials.gov ID
- NCT01813422
- Acronym / sponsor ID
- GLAGOV / 20120153
- Conditions
- Hypercholesterolemia
- Keywords
- Cholesterol, High Cholesterol, Elevated Cholesterol, Raised Cholesterol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 970 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 18 Apr 2013 (actual)
- Primary completion
- 12 Jul 2016 (actual)
- Study completion
- 29 Jul 2016 (actual)
- First posted
- 19 Mar 2013 (estimated)
- Results
- Posted 4 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate whether low-density lipoprotein (LDL-C) lowering with evolocumab (AMG 145) results in greater change from baseline in percent atheroma volume (PAV) at week 78 than placebo in adults with coronary artery disease taking lipid lowering therapy.
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 to evolocumab administered by subcutaneous injection once a month for 76 weeks. |
| Evolocumab | Experimental | Biological: EvolocumabParticipants received 420 mg evolocumab administered by subcutaneous injection once a month for 76 weeks. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Clinical indication for coronary angiography
- Subjects already taking statin therapy, niacin or ezetimibe at screening must have been on a stable dose for at least 4 weeks prior to screening LDL-C. Subjects not taking lipid-regulating therapy must enter the study via a lipid stabilization period. Subjects who are intolerant to statins must meet statin intolerance entry criteria
- Fasting LDL-C ≥ 80 mg/dL (2.07 mmol/L) with or without additional risk factors, or, LDL-C ≥ 60 -< 80 mg/dL (1.55-2.07 mmol/L) in the presence of one major or three minor risk factors
- Subjects must meet the following criteria at the qualifying coronary catheterization procedure:
- Evidence of coronary heart disease (at least one lesion in a native coronary artery that has > 20% reduction in lumen diameter) or prior percutaneous intervention (PCI)
Key exclusion criteria (8 listed)
- Coronary artery bypass graft surgery < 6 weeks prior to the qualifying IVUS
- New York Heart Association (NYHA) III or IV heart failure, or last known left ventricular ejection fraction less than 30%
- Uncontrolled cardiac arrhythmia that is not controlled by medications in the 3 months prior to randomization
- Known hemorrhagic stroke
- Uncontrolled hypertension at randomization
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, Repatha®Administered by subcutaneous injection | Biological | Evolocumab |
| PlaceboAdministered by subcutaneous injection | Drug | Placebo |
Primary outcome
Change From Baseline in Percent Atheroma Volume at Week 78
Time frame: Baseline and week 78
Intravascular ultrasound (IVUS) was used to visualize the extent of atherosclerotic plaques in the coronary artery lumen. The extent of atherosclerosis was expressed as percent atheroma volume (PAV) in a ≥ 40 mm segment of one targeted (imaged) coronary artery, calculated as the percentage of the total vessel volume occupied by atheroma.
3 secondary outcomes
Change From Baseline in Total Atheroma Volume at Week 78
Time frame: Baseline and week 78
Percentage of Participants With Regression in Percent Atheroma Volume
Time frame: Baseline and week 78
Percentage of Participants With Regression in Total Atheroma Volume
Time frame: Baseline and week 78
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27846344Nicholls SJ, Puri R, Anderson T, Ballantyne CM, Cho L, Kastelein JJ, Koenig W, Somaratne R, Kassahun H, Yang J, Wasserman SM, Scott R, Ungi I, Podolec J, Ophuis AO, Cornel JH, Borgman M, Brennan DM, Nissen SE. Effect of Evolocumab on Progression of Coronary Disease in Statin-Treated Patients: The GLAGOV Randomized Clinical Trial. JAMA. 2016 Dec 13;316(22):2373-2384. doi: 10.1001/jama.2016.16951.
- Background: PubMed 30336824Nicholls SJ, Puri R, Anderson T, Ballantyne CM, Cho L, Kastelein JJP, Koenig W, Somaratne R, Kassahun H, Yang J, Wasserman SM, Honda S, Shishikura D, Scherer DJ, Borgman M, Brennan DM, Wolski K, Nissen SE. Effect of Evolocumab on Coronary Plaque Composition. J Am Coll Cardiol. 2018 Oct 23;72(17):2012-2021. doi: 10.1016/j.jacc.2018.06.078.
- Derived from this study: PubMed 33078867Schmidt AF, Carter JL, Pearce LS, Wilkins JT, Overington JP, Hingorani AD, Casas JP. PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2020 Oct 20;10(10):CD011748. doi: 10.1002/14651858.CD011748.pub3.
- Derived from this study: PubMed 27264224Puri R, Nissen SE, Somaratne R, Cho L, Kastelein JJ, Ballantyne CM, Koenig W, Anderson TJ, Yang J, Kassahun H, Wasserman SM, Scott R, Borgman M, Nicholls SJ. Impact of PCSK9 inhibition on coronary atheroma progression: Rationale and design of Global Assessment of Plaque Regression with a PCSK9 Antibody as Measured by Intravascular Ultrasound (GLAGOV). Am Heart J. 2016 Jun;176:83-92. doi: 10.1016/j.ahj.2016.01.019. Epub 2016 Feb 17.
- 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
226 sites in 32 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 Hypercholesterolemia, run by Amgen at 226 sites in 32 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 7 inclusion and 8 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 20 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 226 sites in United States, Canada, Australia, Netherlands, Argentina and 27 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 4 Jan 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?
Change From Baseline in Percent Atheroma Volume at Week 78 (time frame: Baseline and week 78). 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 NCT01813422, which also lists 4 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 20 Feb 2019.