Diabetes Mellitus, Type 2Phase 3THEMISNCT01991795

A Study Comparing Cardiovascular Effects of Ticagrelor Versus Placebo in Patients With Type 2 Diabetes Mellitus

A Phase 3 study testing Ticagrelor 60 mg in people with Diabetes Mellitus, Type 2, run by AstraZeneca at 1,237 sites in 43 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to compare the effect of ticagrelor versus placebo in patients with Type 2 Diabetes Mellitus. Read more about this study

Who is it for?: Ages 50 to 130 years
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: Ticagrelor 60 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 19,271 participants
Where: 1,237 sitesin 43 countries
Study dates: 10 Feb 2014to 25 Jan 2019
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 50 to 130 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Men or women ≥50 years of age with type 2 diabetes mellitus on treatment with a glucose lowering medication since at least 6 months, and either documented coronary artery occlusive disease or previous revascularization of a coronary artery.

Who cannot join

History of myocardial infarction or any stroke; planned treatment with agents inhibiting blood clotting; planned use of ASA/Aspirin at doses above 150 mg daily; planned coronary, cerebrovascular, or peripheral arterial revascularization; patients with known bleeding disorders and patients who need chronic oral anticoagulant therapy or chronic low-molecular-weight heparin; history of intracranial bleeding at any time, or a history of bleeding from the gastrointestinal tract within the last 6 months or a major surgery within the last 30 days; patients with known severe liver disease or with kidney failure requiring dialysis

Trial locations and contacts

1,237 sites in 43 countries.

Country

City, postcode or hospital

1237 sites in 43 countries

United States295 sites

Research Site
Akron, Ohio, 44302
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Albany, New York, 12203
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Albuquerque, New Mexico, 87102
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Alexander City, Alabama, 35010
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Alexandria, Louisiana, 71301
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Alexandria, Virginia, 22304
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Amarillo, Texas, 79106
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Anaheim, California, 92801
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Anderson, Indiana, 46011
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Arlington, Texas, 76012
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Arlington, Virginia, 22205
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Arlington Heights, Illinois, 60005
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Asheville, North Carolina, 28803
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Atlanta, Georgia, 30322
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Auburn, Maine, 04210
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Austin, Texas, 78705
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Austin, Texas, 78709
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Bakersfield, California, 93309
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Baltimore, Maryland, 21215-5271
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Baltimore, Maryland, 21218
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Bangor, Maine, 04401
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Beaumont, Texas, 77702
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Beverly Hills, California, 90211
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Biloxi, Mississippi, 39531
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Binghamton, New York, 13901
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Birmingham, Alabama, 35211
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Bossier City, Louisiana, 71111
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Bountiful, Utah, 84010
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Bowie, Maryland, 20715
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Bradenton, Florida, 34209
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Bridgeport, Connecticut, 06610
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Bridgewater, New Jersey, 08807
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Bristol, Tennessee, 37620
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Buffalo, New York, 14215
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Butler, Pennsylvania, 16001
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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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Channelview, Texas, 77530
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Chicago, Illinois, 60631
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Chicago, Illinois, 60654
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Cincinnati, Ohio, 45227
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Clayton, North Carolina, 27520
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Clearwater, Florida, 33756
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Cleveland, Ohio, 44122
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Cleveland, Ohio, 44126
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Columbia, South Carolina, 29204
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Columbia, South Carolina, 29205
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Columbia, South Carolina, 29209-1639
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Columbus, Georgia, 31904
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Cooper City, Florida, 33024
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Coral Springs, Florida, 33065
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Cottonwood, Arizona, 86326
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Covington, Louisiana, 70433
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Crestview Hills, Kentucky, 41017
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Crowley, Louisiana, 70526
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Crystal Lake, Illinois, 60012
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Crystal River, Florida, 34429
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Cumming, Georgia, 30041
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Cutler Bay, Florida, 33189
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Dallas, Texas, 75216
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Dallas, Texas, 75231
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Dallas, Texas, 75390-9184
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Danville, Pennsylvania, 17822
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Danville, Virginia, 24541
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Davenport, Iowa, 52803
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Dayton, Ohio, 45419
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Daytona Beach, Florida, 32114
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Decatur, Georgia, 30012
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Decatur, Georgia, 30032
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DeLand, Florida, 32720
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Denver, Colorado, 80239-3133
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Detroit, Michigan, 48202
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Doylestown, Pennsylvania, 18901
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Draper, Utah, 84020
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Duluth, Minnesota, 55805
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East Brunswick, New Jersey, 08816
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Elkhart, Indiana, 46514
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Elmhurst, Illinois, 60126
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Erie, Pennsylvania, 16502
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Evanston, Illinois, 60201
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Fairhope, Alabama, 36532
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Falls Church, Virginia, 22042
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Fargo, North Dakota, 58103
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Fargo, North Dakota, 58104
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Flemington, New Jersey, 08822
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Fort Lauderdale, Florida, 33312
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Fort Sam Houston, Texas, 78234
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Fort Wayne, Indiana, 46845
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Fort Worth, Texas, 76107
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Fort Worth, Texas, 76116
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Fremont, California, 94538
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Fresno, California, 93721
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Gainesville, Georgia, 30501
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Georgetown, Texas, 78626
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Glen Burnie, Maryland, 21061
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Glendale, Arizona, 85306
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Greenbelt, Maryland, 20770
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Greenfield, Indiana, 46140
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Greenwich, Connecticut, 06830
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Greenwood, South Carolina, 29646
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Gurnee, Illinois, 60031
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Harleysville, Pennsylvania, 19438
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Hastings, Nebraska, 68901
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Haverhill, Massachusetts, 01830
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Hawthorne, New York, 10532
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Helena, Montana, 59601
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Hialeah, Florida, 33012
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Hialeah, Florida, 33013
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High Point, North Carolina, 27265
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Hillsboro, Oregon, 97123-4117
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Hinsdale, Illinois, 60521
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Hollywood, Florida, 33021
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Houston, Texas, 77024
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Houston, Texas, 77025
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Houston, Texas, 77036
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Houston, Texas, 77043
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Houston, Texas, 77058
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Houston, Texas, 77062
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Houston, Texas, 77070
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Houston, Texas, 77090
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Huntington, West Virginia, 25701
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Huntsville, Alabama, 35801
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Huntsville, Alabama, 35803
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Huntsville, Texas, 77340
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Indiana, Pennsylvania, 15701
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Indianapolis, Indiana, 460202
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Indianapolis, Indiana, 46227
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Irvine, California, 92614
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Jackson, Michigan, 49201
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Jackson, Mississippi, 39216
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Jackson, Tennessee, 38305
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Jacksonville, Florida, 32204
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Jacksonville, Florida, 32209
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Jacksonville, Florida, 32216
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Joplin, Missouri, 64804
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Kalamazoo, Michigan, 49009
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Kansas City, Missouri, 64108
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Kansas City, Missouri, 64111
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Katy, Texas, 77450
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Kenosha, Wisconsin, 53144
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Kettering, Ohio, 45429
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Kingwood, Texas, 77339
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Knoxville, Tennessee, 37917
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Knoxville, Tennessee, 37934
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La Mesa, California, 91942
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Lake Worth, Florida, 33467
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Largo, Florida, 33707
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Las Vegas, Nevada, 89128
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Lee's Summit, Missouri, 64064
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Lenoir, North Carolina, 28645
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Lincoln, Nebraska, 68506
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Lincoln, Nebraska, 68526
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Little Rock, Arkansas, 72204
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Little Rock, Arkansas, 72205
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Little Rock, Arkansas, 72211
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Long Beach, California, 90806
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Long Beach, California, 90807
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Los Alamitos, California, 90720
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Los Angeles, California, 90033
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Los Angeles, California, 90036
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Los Angeles, California, 90067
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Lubbock, Texas, 79430
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Lyndhurst, Ohio, 44124
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Manassas, Virginia, 20109
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Manassas, Virginia, 20110
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Manhasset, New York, 11030
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McAllen, Texas, 78503
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Medford, Oregon, 97504
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Merritt Island, Florida, 32953
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Miami, Florida, 33126
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Miami, Florida, 33134
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Miami, Florida, 33135
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Miami, Florida, 33136
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Miami, Florida, 33144
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Miami, Florida, 33155
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Miami, Florida, 33165
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Miami, Florida, 33166
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Miami, Florida, 33173
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Miami, Florida, 33174
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Miami, Florida, 33176
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Miami, Florida, 33186
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Miami Gardens, Florida, 33169
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Miami Shores, Florida, 33012
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Miami Springs, Florida, 33166
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Minden, Louisiana, 71055
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Mission Hills, California, 91345
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Mobile, Alabama, 36608
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Moline, Illinois, 61265
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Monroe, Louisiana, 71201
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Montgomery, Alabama, 36111
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Morganton, North Carolina, 28655
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Morristown, New Jersey, 08057
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Mount Clemens, Michigan, 48043
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Muncie, Indiana, 47303
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Muncie, Indiana, 47304
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Munster, Indiana, 46321
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Nampa, Idaho, 83687
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Naples, Florida, 34102
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Nashville, Tennessee, 37204
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New Smyrna Beach, Florida, 32169
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New Windsor, New York, 12553
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New York, New York, 10001
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New York, New York, 10029
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Newport, Pennsylvania, 17074
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Newport Beach, California, 92663
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North Attleboro, Massachusetts, 02760
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North Chicago, Illinois, 60064
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North Kansas City, Missouri, 64116
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North Miami Beach, Florida, 33162
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North Myrtle Beach, South Carolina, 29582
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Ocala, Florida, 34471
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Oklahoma City, Oklahoma, 73103
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Oklahoma City, Oklahoma, 73104
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Oklahoma City, Oklahoma, 73129
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Olive Branch, Mississippi, 38654
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Orchard Park, New York, 14127
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Ormond Beach, Florida, 32174
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Owensboro, Kentucky, 42303
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Oxon Hill, Maryland, 20745
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Panama City, Florida, 32401
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Peoria, Illinois, 61614
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Petoskey, Michigan, 49770
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Pharr, Texas, 78577
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Philadelphia, Pennsylvania, 19141
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Pinehurst, North Carolina, 28374
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Pittsburgh, Pennsylvania, 15240
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Plano, Texas, 75024
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Plano, Texas, 75093
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Pontiac, Michigan, 48341
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Port Charlotte, Florida, 33952
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Port Matilda, Pennsylvania, 16870
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Port Orchard, Washington, 98366
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Poughkeepsie, New York, 12601
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Prince Frederick, Maryland, 20678
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Providence, Rhode Island, 02903
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Providence, Rhode Island, 02906
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Raleigh, North Carolina, 27610
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Rapid City, South Dakota, 57701
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Roanoke, Virginia, 24014
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Rochester Hills, Michigan, 48307
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Rock Hill, South Carolina, 29732
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Rocky Mount, North Carolina, 27804
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Sacramento, California, 95821
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Saint Cloud, Florida, 34769
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Saint Paul, Minnesota, 55102
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Salisbury, Maryland, 21804
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Salt Lake City, Utah, 84124
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San Antonio, Texas, 78224
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San Antonio, Texas, 78231
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San Diego, California, 92103
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San Diego, California, 92122
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Sanford, North Carolina, 27330
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Saratoga Springs, New York, 12866
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Scranton, Pennsylvania, 18510
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Seattle, Washington, 98104
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Shavano Park, Texas, 78231
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Sheffield, Alabama, 35660
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Shreveport, Louisiana, 71103
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Shreveport, Louisiana, 71105
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Simpsonville, South Carolina, 29681
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Sioux Falls, South Dakota, 57108
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Slidell, Louisiana, 70458
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Smithfield, North Carolina, 27577
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Somerset, New Jersey, 08873
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Springfield, Ohio, 45504
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St Louis, Missouri, 63110
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St Louis, Missouri, 63128
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St Louis, Missouri, 63136
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Stanford, California, 94305-5235
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Stockton, California, 95204
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Stony Brook, New York, 11794-8167
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Tabor City, North Carolina, 28463
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Tarzana, California, 91356
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The Bronx, New York, 10467
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Toms River, New Jersey, 08755
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Torrance, California, 90509
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Troy, Michigan, 48098
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Tucker, Georgia, 30084
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Tucson, Arizona, 85741
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Tullahoma, Tennessee, 37388
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Tupelo, Mississippi, 38801
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Tuscumbia, Alabama, 35674
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Utica, New York, 13501
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Varnville, South Carolina, 29924
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Voorhees Township, New Jersey, 08043
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Waukesha, Wisconsin, 53188
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West Des Moines, Iowa, 50265
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Wichita, Kansas, 67214
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Willoughby, Ohio, 44094
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Winston-Salem, North Carolina, 27103
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Wyomissing, Pennsylvania, 19610
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Yardley, Pennsylvania, 19067
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Youngstown, Ohio, 44501

Other trials in United States

Poland78 sites

Research Site
Biała Rawska, 96-230
Research Site
Bialystok, 15-276
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Bialystok, 15-351
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Bialystok, 15-875
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Bielsko-Biala, 43-316
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Bochnia, 32-700
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Bydgoszcz, 85-079
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Bydgoszcz, 85-231
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Bydgoszcz, 85-796
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Chojnice, 89-600
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Chorzów, 41-500
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Chrzanów, 32-500
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Elblag, 82-300
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Gdansk, 80-286
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Gdansk, 80-437
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Gdansk, 80-546
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Gdansk, 80-952
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Gdynia, 81-157
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Gdynia, 81-423
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Gdynia, 81-472
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Giżycko, 11-500
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Grodzisk Mazowiecki, 05-825
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Jasło, 38-200
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Katowice, 40-081
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Katowice, 40-748
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Katowice, 40-752
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Kędzierzyn-Koźle, 47-200
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Kielce, 25-525
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Kościan, 64-000
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Koszalin, 75-256
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Krakow, 31-156
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Krakow, 31-202
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Krakow, 31-559
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Legnica, 59-220
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Lodz, 94-238
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Lubin, 59-301
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Lublin, 20-044
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Lublin, 20-362
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Lublin, 20-538
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Lublin, 20-709
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Mikołów, 43-190
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Myszków, 42-300
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Nakło nad Notecią, 89-100
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Nowogard, 72-200
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Nysa, 48-300
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Opole, 45-056
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Ostrów Mazowiecka, 07-300
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Oświęcim, 32-600
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Płock, 09-402
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Poznan, 60-821
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Poznan, 61-655
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Puławy, 24-100
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Ruda Śląska, 41-709
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Rzeszów, 35-055
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Rzeszów, 35-205
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Siedlce, 08-110
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Sobótka, 55-050
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Sokółka, 16-100
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Staszów, 28-200
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Szczecin, 70-506
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Szczecin, 71-531
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Tarnów, 33-100
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Torun, 87-100
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Tychy, 43-100
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Ustroń, 43-450
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Warsaw, 02-097
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Warsaw, 02-679
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Warsaw, 04-628
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Warsaw, 05-077
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Wierzchosławice, 33-122
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Włocławek, 87-800
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Wroclaw, 50-127
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Wroclaw, 50-555
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Zabrze, 41-800
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Zamość, 22-400
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Zgierz, 95-100
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Zielona Góra, 65-036
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Żnin, 88-400

Other trials in Poland

Russia67 sites

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Arkhangelsk, 163001
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Gatchina, 188300
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Ivanovo, 153012
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Izhevsk, 426063
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Kaluga, 248010
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Kazan', 420012
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Kazan', 420043
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Kazan', 420103
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Kemerovo, 650000
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Kemerovo, 650002
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Khanty-Mansiysk, 628012
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Krasnodar, 350012
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Krasnodar, 350042
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Krasnodar, 350086
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Moscow, 105187
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Moscow, 109263
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Moscow, 115516
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Moscow, 117292
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Moscow, 117556
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Moscow, 117997
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Moscow, 119121
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Moscow, 119991
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Moscow, 121309
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Moscow, 121359
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Moscow, 121374
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Moscow, 121552
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Moscow, 125284
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Moscow, 129327
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Nizhny Novgorod, 603076
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Novosibirsk, 630008
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Novosibirsk, 630055
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Novosibirsk, 630099
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Omsk, 644043
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Omsk, 644111
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Omsk, 644112
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Perm, 614000
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Perm, 614068
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Perm, 6144090
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Rostov-on-Don, 344068
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Ryazan, 390026
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Ryazan, 390039
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Saint Petersburg, 192148
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Saint Petersburg, 192242
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Saint Petersburg, 194017
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Saint Petersburg, 194044
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Saint Petersburg, 194156
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Saint Petersburg, 194354
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Saint Petersburg, 195030
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Saint Petersburg, 195067
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Saint Petersburg, 196143
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Saint Petersburg, 196601
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Saint Petersburg, 197341
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Saint Petersburg, 198013
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Saint Petersburg, 198412
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Saint Petersburg, 199106
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Saratov, 410039
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StPetersburg, 193312
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Tomsk, 634012
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Tver', 170036
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Tyumen, 625000
Research Site
Tyumen, 625026
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Ufa, 450071
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Vladimir, 600023
Research Site
Volgograd, 400131
Research Site
Yaroslavl, 150062
Research Site
Yekaterinburg, 620039
Research Site
Yekaterinburg, 620043

Other trials in Russia

Canada63 sites

Research Site
Brampton, Ontario, L6W 2X7
Research Site
Brossard, Quebec, J4Z 2K9
Research Site
Calgary, Alberta, T2V 4J2
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Cambridge, Ontario, N1R 6V6
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Cambridge, Ontario, N1R 7L6
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Cambridge, Ontario, N1R 7R1
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Chicoutimi, Quebec, G7H 7K9
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Chicoutimi, G7H 5H6
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Cornwall, Ontario, K6H 4M4
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Edmonton, Alberta, T5A 4L8
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Edmonton, Alberta, T5H 3V9
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Edmonton, Alberta, T6G 2E1
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Greater Sudbury, Ontario, P3E 5M4
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Greenfield Park, Quebec, J4V 2G8
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Halifax, Nova Scotia, B3H 3A7
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Halifax, Nova Scotia, B3S 1M7
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Hamilton, Ontario, L8L 2X2
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Jarvis, Ontario, N0A 1J0
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Kelowna, British Columbia, V1Y 1V6
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Laval, Quebec, H7M 3L9
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Laval, Quebec, H7T 2P5
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London, Ontario, N6A 5A5
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London, Ontario, N6G 2M1
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Longueuil, Quebec, J4M 2X1
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Montreal, Quebec, H1M 1B1
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Montreal, Quebec, H1T 1C8
Research Site
Montreal, Quebec, H1T 3Y7
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Montreal, Quebec, H2W 1T8
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Montreal, Quebec, H3G 1A4
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Mount Pearl, Newfoundland and Labrador, A1N 1W7
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New Westminster, British Columbia, V3L 3W4
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Newmarket, Ontario, L3Y 2R2
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Newmarket, Ontario, L3Y 5G8
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North York, Ontario, M3M 3E5
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Oshawa, Ontario, L1J 2K1
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Ottawa, Ontario, K1Y 4W7
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Penticton, British Columbia, V2A 5C8
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Québec, Quebec, G1G 3Y8
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Québec, Quebec, G1N 4V3
Research Site
Québec, Quebec, G1V 4G5
Research Site
Québec, Quebec, G1W 4R4
Research Site
Québec, Quebec, G2J 0C4
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Red Deer, Alberta, T4N 6V7
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Regina, Saskatchewan, S4P 0W5
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Saint John, New Brunswick, E2L 4L2
Research Site
Saint-Charles-Borromée, Quebec, J6E 6J2
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Saint-Georges, Quebec, G5Y 4T8
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Saint-Jean-sur-Richelieu, Quebec, J3A 1J2
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Saint-Lambert, Quebec, J4P 2H4
Research Site
Sarnia, Ontario, N7T 4X3
Research Site
Scarborough Village, Ontario, M1E 5E9
Research Site
Scarborough Village, Ontario, M1R 3A6
Research Site
Spruce Grove, Alberta, T7X 2V2
Research Site
St. John's, Newfoundland and Labrador, A1A 3R5
Research Site
St. John's, Newfoundland and Labrador, A1B 3V6
Research Site
Surrey, British Columbia, V3V 0C6
Research Site
Terrebonne, Quebec, J6V 2H2
Research Site
Thornhill, Ontario, L4J 1W3
Research Site
Toronto, Ontario, M5B 1W8
Research Site
Toronto, Ontario, M5G 2C4
Research Site
Vancouver, British Columbia, V5Z 1M9
Research Site
Victoria, British Columbia, V8R 4R2
Research Site
Waterloo, Ontario, N2T 0C1

Other trials in Canada

Japan52 sites

Research Site
Adachi-ku, 123-0845
Research Site
Beppu-shi, 874-0011
Research Site
Chikushino-shi, 818-8516
Research Site
Chūōku, 103-0027
Research Site
Daito-shi, 574-0074
Research Site
Edogawa-ku, 134-8678
Research Site
Fujisawa-shi, 251-0041
Research Site
Fukui-shi, 910-8526
Research Site
Fukuoka, 810-8563
Research Site
Funabashi-shi, 274-0065
Research Site
Fussa-shi, 197-8511
Research Site
Gifu, 500-8384
Research Site
Hachioji-shi, 192-0918
Research Site
Hitachi-shi, 317-0077
Research Site
Isehara-shi, 259-1193
Research Site
Iwakuni-shi, 740-8510
Research Site
Kagoshima, 892-0853
Research Site
Kawanishi-shi, 666-0125
Research Site
Kishiwada-shi, 596-8522
Research Site
Kobe, 651-0073
Research Site
Koga-shi, 811-3195
Research Site
Koriyama-shi, 963-8052
Research Site
Kumamoto, 860-0008
Research Site
Kure-shi, 737-0023
Research Site
Kurume-shi, 830-0011
Research Site
Kyoto, 612-8555
Research Site
Matsudo-shi, 271-0077
Research Site
Miura-gun, 240-0116
Research Site
Okayama, 700-0804
Research Site
Osaka, 554-0012
Research Site
Osaka, 559-0012
Research Site
Otaru-shi, 047-8510
Research Site
Sanyoonoda-shi, 756-0095
Research Site
Sapporo, 060-0031
Research Site
Sapporo, 060-0033
Research Site
Sapporo, 063-0005
Research Site
Sayama-shi, 350-1305
Research Site
Shimajiri-gun, 901-0493
Research Site
Takamatsu, 760-0018
Research Site
Takasaki-shi, 370-0036
Research Site
Takasaki-shi, 370-3513
Research Site
Takayama-shi, 506-8550
Research Site
Toyohashi, 440-8510
Research Site
Toyota-shi, 471-8513
Research Site
Tsuchiura-shi, 300-0053
Research Site
Uji-shi, 611-0041
Research Site
Urasoe-shi, 901-2132
Research Site
Ureshino-shi, 843-0393
Research Site
Wakayama, 649-6335
Research Site
Wako-shi, 351-0102
Research Site
Yokohama, 236-0051
Research Site
Yokohama, 247-8581

Other trials in Japan

Brazil42 sites

Research Site
Belo Horizonte, 30110070
Research Site
Belo Horizonte, 30150-240
Research Site
Belo Horizonte, 30190-130
Research Site
Blumenau, 89010-906
Research Site
Brasília, 70658-700
Research Site
Brasília, 71625-175
Research Site
Brasillia, 70200-730
Research Site
Brasillia, 70710-100
Research Site
Campina Grande do Sul, 83430000
Research Site
Campinas, 13010-001
Research Site
Campinas, 13060 904
Research Site
Campo Grande, 79080-190
Research Site
Cariacica, 29156-580
Research Site
Curitiba, 80230-130
Research Site
Curitiba, 80320-320
Research Site
Curitiba, 80730-150
Research Site
Fortaleza, 60120-021
Research Site
Fortaleza, 60170-320
Research Site
Fortaleza, 60416-200
Research Site
Fortaleza, 60864190
Research Site
Goiânia, 74110-010
Research Site
Goiânia, 74223-130
Research Site
Marília, 17515-000
Research Site
Maringá, 87015-000
Research Site
Porto Alegre, 90020-090
Research Site
Porto Alegre, 90035-003
Research Site
Porto Alegre, 90110-270
Research Site
Porto Alegre, 90620-001
Research Site
Porto Alegre, 91350200
Research Site
Ribeirão Preto, 14048900
Research Site
Rio de Janeiro, 22271-100
Research Site
S.J.Rio Preto, 15090-000
Research Site
São José dos Campos, 12243-280
Research Site
São Paulo, 01228-200
Research Site
São Paulo, 04012-180
Research Site
São Paulo, 04266-010
Research Site
São Paulo, 05403-000
Research Site
Tatuí, 18270-170
Research Site
Uberlândia, 38400-368
Research Site
Vitória, 29047-575
Research Site
Vitória, 29055-450
Research Site
Votuporanga, 15500-003

Other trials in Brazil

Ukraine39 sites

Research Site
Belo Horizonte, 30110025
Research Site
Cherkasy, 18009
Research Site
Dnipro, 49027
Research Site
Dnipro, 49064
Research Site
Dnipro, 49070
Research Site
Ivano-Frankivsk, 76005
Research Site
Ivano-Frankivsk, 76018
Research Site
Kharkiv Region, 61002
Research Site
Kharkiv Region, 61018
Research Site
Kharkiv Region, 61039
Research Site
Kharkiv Region, 61058
Research Site
Kharkiv Region, 61176
Research Site
Kyiv, 01014
Research Site
Kyiv, 01601
Research Site
Kyiv, 02002
Research Site
Kyiv, 02091
Research Site
Kyiv, 02660
Research Site
Kyiv, 03110
Research Site
Kyiv, 03151
Research Site
Kyiv, 03680
Research Site
Kyiv, 04050
Research Site
Kyiv, 04053
Research Site
Kyiv, 04114
Research Site
Lutsk, 43024
Research Site
Lviv, 79010
Research Site
Lviv, 79015
Research Site
Mykolaiv, 54003
Research Site
Odesa, 65025
Research Site
Odesa, 65082
Research Site
Odesa, 65114
Research Site
Poltava, 36038
Research Site
Rivne, 33007
Research Site
Ternopil, 46010
Research Site
Uzhhorod, 88014
Research Site
Vinnytsia, 21005
Research Site
Vinnytsia, 21018
Research Site
Vinnytsia, 21021
Research Site
Zaporizhzhya, 69068
Research Site
Zaporizhzhya, 69600

Other trials in Ukraine

Spain37 sites

Research Site
A Coruña, 15006
Research Site
Alcalá de Henares, 28805
Research Site
Alicante, 03010
Research Site
Barcelona, 08003
Research Site
Barcelona, 08022
Research Site
Barcelona, 08035
Research Site
Barcelona, 08036
Research Site
Barcelona, 08041
Research Site
Bilbao, 48013
Research Site
Cáceres, 10003
Research Site
El Palmar, 30120
Research Site
Ferrol (A Coruña), 15405
Research Site
Girona, 17007
Research Site
Granada, 18012
Research Site
Huelva, 21005
Research Site
L'Hospitalet de Llobregat, 08907
Research Site
La Laguna (Tenerife), 38320
Research Site
Madrid, 28006
Research Site
Madrid, 28007
Research Site
Madrid, 28031
Research Site
Madrid, 28034
Research Site
Madrid, 28040
Research Site
Madrid, 28041
Research Site
Majadahonda, 28222
Research Site
Málaga, 29010
Research Site
Móstoles, 28933
Research Site
Pontevedra, 36312
Research Site
Sabadell, 08208
Research Site
San Sebastián de los Reyes, 28702
Research Site
Sant Joan d'Alacant, 03550
Research Site
Santander, 39008
Research Site
Santiago(A Coruña), 15706
Research Site
Seville, 41014
Research Site
Seville, 41071
Research Site
Son Ferriol, 07198
Research Site
Valdemoro, 28342
Research Site
Valencia, 46010

Other trials in Spain

Bulgaria33 sites

Research Site
Blagoevgrad, 2700
Research Site
Botevgrad, 2140
Research Site
Burgas, 8018
Research Site
Dimitrovgrad, 6400
Research Site
Dupnitsa, 2600
Research Site
Gabrovo, 5300
Research Site
Haskovo, 6300
Research Site
Kozloduy, 3320
Research Site
Kyustendil, 2500
Research Site
Lom, 3600
Research Site
Pazardzhik, 4400
Research Site
Pleven, 5800
Research Site
Plovdiv, 4000
Research Site
Plovdiv, 4002
Research Site
Plovdiv, 4003
Research Site
Rousse, 7003
Research Site
Sandanski, 2800
Research Site
Sevlievo, 5400
Research Site
Sliven, 8800
Research Site
Sofia, 1142
Research Site
Sofia, 1233
Research Site
Sofia, 1324
Research Site
Sofia, 1404
Research Site
Sofia, 1407
Research Site
Sofia, 1408
Research Site
Sofia, 1431
Research Site
Sofia, 1463
Research Site
Sofia, 1527
Research Site
Sofia, 1606
Research Site
Sofia, 1709
Research Site
Stara Zagora, 6000
Research Site
Varna, 9000
Research Site
Yambol, 8600

Other trials in Bulgaria

Czechia32 sites

Research Site
Benešov, 256 01
Research Site
Brno, 602 00
Research Site
Brno, 62500
Research Site
Brno, 638 00
Research Site
Brno, 639 00
Research Site
Česká Lípa, 470 77
Research Site
Chomutov, 430 02
Research Site
Frýdek-Místek, 738 01
Research Site
Jablonec nad Nisou, 466 60
Research Site
Karlovy Vary, 360 01
Research Site
Kolín, 280 00
Research Site
Kutná Hora, 284 30
Research Site
Louny, 440 01
Research Site
Olomouc, 772 52
Research Site
Ostrava, 702 00
Research Site
Ostrava-Dubina, 700 30
Research Site
Pelhřimov, 393 01
Research Site
Prague, 10034
Research Site
Prague, 110 00
Research Site
Prague, 12808
Research Site
Prague, 130 00
Research Site
Prague, 150 00
Research Site
Prague, 150 06
Research Site
Prague, 158 00
Research Site
Prague, 190 00
Research Site
Pribram VIII, 260 01
Research Site
Slaný, 274 01
Research Site
Třebíč, 674 01
Research Site
Turnov, 511 01
Research Site
Ústí nad Labem, 400 11
Research Site
Ústí nad Orlicí, 562 18
Research Site
Zábřeh nad Odrou, 700 30

Other trials in Czechia

Germany29 sites

Research Site
Altdorf, 90518
Research Site
Aschaffenburg, 63739
Research Site
Bad Krozingen, 79189
Research Site
Berlin, 10117
Research Site
Berlin, 10367
Research Site
Berlin, 10787
Research Site
Berlin, 10789
Research Site
Berlin, 13055
Research Site
Berlin, 13347
Research Site
Berlin, 13405
Research Site
Cologne, 50397
Research Site
Dresden, 01069
Research Site
Dresden, 01099
Research Site
Dresden, 01307
Research Site
Hamburg, 20253
Research Site
Hamburg, 22041
Research Site
Kassel, 34121
Research Site
Leipzig, 04107
Research Site
Leipzig, 04315
Research Site
Markkleeberg, 04416
Research Site
Meißen, 01662
Research Site
Mühldorf, 84453
Research Site
München, 80638
Research Site
Neuwied, 56564
Research Site
Nuremberg, 90402
Research Site
Papenburg, 26871
Research Site
Schwerin, 19055
Research Site
Wangen, 88239
Research Site
Wermsdorf, 04779

Other trials in Germany

Hungary29 sites

Research Site
Balatonfüred, 8230
Research Site
Berettyóújfalu, 4100
Research Site
Budapest, 1032
Research Site
Budapest, 1076
Research Site
Budapest, 1085
Research Site
Budapest, 1096
Research Site
Budapest, 1115
Research Site
Budapest, 1122
Research Site
Budapest, 1134
Research Site
Budapest, 1135
Research Site
Budapest, 1145
Research Site
Budapest, 1213
Research Site
Budapest, H-1106
Research Site
Debrecen, 4032
Research Site
Eger, 3300
Research Site
Hajdúszoboszló, 4200
Research Site
Kalocsa, 6300
Research Site
Kecskemét, 6000
Research Site
Kistarcsa, 2143
Research Site
Kisvárda, 4600
Research Site
Mosonmagyaróvár, 9200
Research Site
Nyíregyháza, 4400
Research Site
Pásztó, 3060
Research Site
Pécs, 7623
Research Site
Sopron, 9400
Research Site
Székesfehérvár, 8000
Research Site
Szentes, 6600
Research Site
Szolnok, 5000
Research Site
Zalaegerszeg, 8900

Other trials in Hungary

United Kingdom27 sites

Research Site
Airdrie, ML6 0JS
Research Site
Antrim, BT41 2RL
Research Site
Belfast, BT63 5QQ
Research Site
Chesterfield, S40 4AA
Research Site
Coventry, CV2 2DX
Research Site
Doncaster, DN9 2HY
Research Site
Dundee, DD1 9SY
Research Site
Durham, DH1 5TW
Research Site
Exeter, EX2 5DW
Research Site
Faringdon, SN7 7YU
Research Site
Glasgow, G12 8TA
Research Site
Harrogate
Research Site
High Wycombe, HP11 2TT
Research Site
London, EC1M 6BQ
Research Site
Middlesbrough, TS4 3BW
Research Site
Newcastle upon Tyne, NE7 7DN
Research Site
Northampton, NN1 5BD
Research Site
Nottingham, NG5 1PB
Research Site
Paisley, PA2 9PN
Research Site
Peterborough, PE3 9GZ
Research Site
Plymouth, PL6 8BX
Research Site
Rotherham, S60 2UD
Research Site
Rothwell, NN14 6JQ
Research Site
Sheffield, S5 7AU
Research Site
Swansea, SA2 8QA
Research Site
Torquay, TQ2 7AA
Research Site
York, YO31 8HE

Other trials in United Kingdom

South Korea26 sites

Research Site
Anyang-si, 431-070
Research Site
Bucheon-si, 14754
Research Site
Busan, 47392
Research Site
Busan, 49241
Research Site
Changwon-si, 51353
Research Site
Cheonan-si, 330-715
Research Site
Cheongju-si, 362-804
Research Site
Daegu, 41944
Research Site
Daegu, 42415
Research Site
Daegu, 42601
Research Site
Daejeon, 301-721
Research Site
Gwangju, 61469
Research Site
Iksan-si, 54538
Research Site
Incheon, 405-760
Research Site
Jeonju, 561-712
Research Site
Jinju, 660-702
Research Site
Seongnam-si, 13620
Research Site
Seoul, 02841
Research Site
Seoul, 03080
Research Site
Seoul, 06591
Research Site
Seoul, 08308
Research Site
Seoul, 110-746
Research Site
Seoul, 130-872
Research Site
Seoul, 135-710
Research Site
Suwon, 16499
Research Site
Wŏnju, 26426

Other trials in South Korea

Netherlands24 sites

Research Site
's-Hertogenbosch, 5223 GZ
Research Site
Alkmaar, 1815 JD
Research Site
Amsterdam, 1061 AE
Research Site
Amsterdam, 1091 AC
Research Site
Arnhem, 6815 AD
Research Site
Beverwijk, 1942 LE
Research Site
Blaricum, 1261 AN
Research Site
Breda, 4818 CK
Research Site
Delft, 2625 AD
Research Site
Eindhoven, 5623 EJ
Research Site
Emmen, 7824 AA
Research Site
Enschede, 7512 KZ
Research Site
Goes, 4462 RA
Research Site
Helmond, 5707 HA
Research Site
Hoofddorp, 2134 TM
Research Site
Hoogeveen, 7909 AA
Research Site
Maastricht, 6202 AZ
Research Site
Roosendaal, 4708 AE
Research Site
Rotterdam, 3045 PM
Research Site
Schiedam, 3118 JH
Research Site
Stadskanaal, 9501 HE
Research Site
Tiel, 4002 WP
Research Site
Uden, 5406 PT
Research Site
Veldhoven, 5504 DB

Other trials in Netherlands

China22 sites

Research Site
Beijing, 100050
Research Site
Bengbu, 233060
Research Site
Cangzhou, 061001
Research Site
Chengdu, 610041
Research Site
Fuzhou, 350025
Research Site
Guangzhou, 510630
Research Site
Jinan, 250001
Research Site
Nanchang, 330006
Research Site
Nanjing, 210009
Research Site
Nanjing, 210012
Research Site
Nanjing, CN-210000
Research Site
Pingxiang, 337055
Research Site
Shanghai, 200025
Research Site
Shanghai, 200032
Research Site
Shanghai, 200065
Research Site
Shanghai, 200090
Research Site
Shenyang, 110016
Research Site
Taiyuan, 030001
Research Site
Tianjin, 300457
Research Site
Wuhan, CN-430022
Research Site
Xi'an, 710061
Research Site
Yinchuan, 750004

Other trials in China

Argentina21 sites

Research Site
Buenos Aires, 1078
Research Site
Buenos Aires, C1425AGC
Research Site
Ciudad Autónoma de Bs. As., C1199ABB
Research Site
Ciudad Autonomade Buenos Aires, 1426
Research Site
Ciudadela, 1702
Research Site
Córdoba, 5000
Research Site
Córdoba, X5000AAW
Research Site
Córdoba, X5008HHW
Research Site
Mar del Plata, 7600
Research Site
Mar del Plata, B7600GNY
Research Site
Ranelagh, 1886
Research Site
Rosario, 2000
Research Site
Rosario, S2000CVD
Research Site
Rosario, S2000DNM
Research Site
San Luis, 5700
Research Site
San Miguel de Tucumán, 4000
Research Site
San Miguel de Tucumán, T4000NIL
Research Site
San Nicolás, B2900DMH
Research Site
Santa Fe, S3000FWO
Research Site
Venado Tuerto, 2600
Research Site
Villa María, 5900

Other trials in Argentina

South Africa21 sites

Research Site
Alberton, 1450
Research Site
Benoni, 1500
Research Site
Bloemfontein, 9301
Research Site
Cape Town, 1730
Research Site
Cape Town, 7405
Research Site
Cape Town, 7460
Research Site
Cape Town, 7500
Research Site
Cape Town, 7550
Research Site
Cape Town, 7570
Research Site
Durban, 4001
Research Site
Durban, 4052
Research Site
Durban, 4170
Research Site
Greenbury, Phoenix, 4068
Research Site
Johannesburg, 2132
Research Site
Johannesburg, 2193
Research Site
KwaDukuza, 4450
Research Site
Paarl, 7646
Research Site
Port Elizabeth, 6001
Research Site
Soweto, 2013
Research Site
Verulam, 4345
Research Site
Worcester, 6830

Other trials in South Africa

Taiwan21 sites

Research Site
Changhua, 50006
Research Site
Hsinchu, 300
Research Site
Hualien City, 970
Research Site
Kaohsiung City, 80756
Research Site
Kaohsiung City, 81362
Research Site
Kaohsiung City, 83301
Research Site
Kaohsiung City
Research Site
Kweishan Shiang, 333
Research Site
New Taipei City, 220
Research Site
New Taipei City, 25160
Research Site
Pingtung City, 928
Research Site
Taichung, 40201
Research Site
Taichung, 40705
Research Site
Taichung
Research Site
Tainan, 704
Research Site
Tainan, 70965
Research Site
Tainan, 710
Research Site
Taipei, 10449
Research Site
Taipei, 11101
Research Site
Taipei, 11217
Research Site
Taipei

Other trials in Taiwan

Mexico19 sites

Research Site
Culiacán, 80020
Research Site
Culiacán, 80200
Research Site
D.F, 14000
Research Site
Guadalajara, 44340
Research Site
Guadalajara, 44670
Research Site
Guadalajara, 44676
Research Site
México, 06700
Research Site
México, 14080
Research Site
Monterrey, 64020
Research Site
Monterrey, 64060
Research Site
Monterrey, 64460
Research Site
Monterrey, 66465
Research Site
Morelia, 58260
Research Site
Nuevo León, 64060
Research Site
Pachuca, 42070
Research Site
Querétaro, 76000
Research Site
Tijuana, 22014
Research Site
Xalapa, 91193
Research Site
Zapopan, 45200

Other trials in Mexico

Belgium17 sites

Research Site
Aalst, 9300
Research Site
Bonheiden, 2820
Research Site
Bouge, 5004
Research Site
Bruges, 8000
Research Site
De Pinte, 9840
Research Site
Genk, 3600
Research Site
Ghent, 9000
Research Site
Hasselt, 3500
Research Site
Huy, 4500
Research Site
Leuven, 3000
Research Site
Liège, 4000
Research Site
Mechelen, 2800
Research Site
Mol, 2400
Research Site
Overpelt, 3900
Research Site
Roeselare, 8800
Research Site
Yvoir, 5530
Research Site
Zottegem, 9620

Other trials in Belgium

France17 sites

Research Site
Avignon, 84902
Research Site
Bayonne, 64100
Research Site
Bobigny, 93000
Research Site
Corbeil-Essonnes, 91100
Research Site
Dijon, 21079
Research Site
La Rochelle, 17019
Research Site
Le Coudray, 28630
Research Site
Lyon, 69007
Research Site
Montauban, 82017
Research Site
Nice, 06001
Research Site
Nîmes, 30006
Research Site
Paris, 75651
Research Site
Paris, 75877
Research Site
Paris, 75908
Research Site
Toulouse, 31059
Research Site
Tourcoing, 59208
Research Site
Tours, 37044

Other trials in France

Italy17 sites

Research Site
Bari, 70131
Research Site
Bergamo, 24128
Research Site
Bologna, 40100
Research Site
Bologna, 40139
Research Site
Florence, 50141
Research Site
Genova, 16100
Research Site
Milan, 20132
Research Site
Milan, 20138
Research Site
Naples, 80131
Research Site
Novara, 28100
Research Site
Pavia, 27100
Research Site
Rivoli, 10098
Research Site
Roma, 00152
Research Site
Roma, 00165
Research Site
San Giovanni Rotondo, 71013
Research Site
Udine, 33100
Research Site
Viterbo, 01100

Other trials in Italy

Chile16 sites

Research Site
Concepción, 4070060
Research Site
Los Ángeles, 4430035
Research Site
Osorno, 5290000
Research Site
Santiago, 7500021
Research Site
Santiago, 7500520
Research Site
Santiago, 7500691
Research Site
Santiago, 7500701
Research Site
Santiago, 7980378
Research Site
Santiago, 8207257
Research Site
Santiago, 8330034
Research Site
Santiago, 8360160
Research Site
Santiago, 8380456
Research Site
Santiago, 8910259
Research Site
Talcahuano, 4270918
Research Site
Temuco, 4810371
Research Site
Viña del Mar, 2520997

Other trials in Chile

Norway16 sites

Research Site
Ålesund, N-6003
Research Site
Bergen, N-5009
Research Site
Bodø, N-8092
Research Site
Bodø, NO8008
Research Site
Kongsvinger, N-2212
Research Site
Lillehammer, N-2629
Research Site
Oslo, 0372
Research Site
Oslo, N-0953
Research Site
Oslo, NO-1157
Research Site
Sandefjord, N-3211
Research Site
Skedsmokorset, N-2020
Research Site
Skien, N-3710
Research Site
Stavanger, N-4011
Research Site
Svelvik, N-3060
Research Site
Tromsø, N-9038
Research Site
Trondheim, N-7462

Other trials in Norway

Slovakia15 sites

Research Site
Banská Bystrica, 974 05
Research Site
Bratislava, 841 08
Research Site
Brezno, 97742
Research Site
Košice, 040 01
Research Site
Košice, 04022
Research Site
Kráľovský Chlmec, 077 01
Research Site
Liptovský Mikuláš, 031 01
Research Site
Lučenec, 984 01
Research Site
Martin, 036 01
Research Site
Nitra, 949 01
Research Site
Prešov, 080 01
Research Site
Ružomberok, 034 26
Research Site
Svidník, 08901
Research Site
Trnava, 917 01
Research Site
Žilina, 010 01

Other trials in Slovakia

Australia14 sites

Research Site
Adelaide, 5000
Research Site
Ashford, 5035
Research Site
Coffs Harbour, 2450
Research Site
Fitzroy, 3065
Research Site
Fullarton, 5063
Research Site
Geelong, 3220
Research Site
Heidelberg West, 3081
Research Site
Herston, 4029
Research Site
Joondalup, 6027
Research Site
Maroubra, 2035
Research Site
Melbourne, 3004
Research Site
Merewether, 2291
Research Site
Milton, 4064
Research Site
Murdoch, 6150

Other trials in Australia

Peru14 sites

Research Site
Arequipa, 04000
Research Site
Callao, CALLAO 02
Research Site
Callao, CALLAO 2
Research Site
Chiclayo, 14000
Research Site
Lima, 14
Research Site
Lima, 31
Research Site
Lima, L11
Research Site
Lima, L33
Research Site
Lima, L41
Research Site
Lima, LIMA 01
Research Site
Lima, LIMA 27
Research Site
Lima, LIMA 32
Research Site
Lima, LIMA 41
Research Site
Miraflores, 15046

Other trials in Peru

Sweden14 sites

Research Site
Gothenburg, 413 45
Research Site
Jönköping, 551 85
Research Site
Lessebo, 365 32
Research Site
Lund, 222 21
Research Site
Lund, 222 42
Research Site
Malmö, 205 02
Research Site
Örebro, 703 62
Research Site
Rättvik, 79530
Research Site
Stockholm, 112 81
Research Site
Stockholm, 118 83
Research Site
Stockholm, 141 86
Research Site
Stockholm, 182 88
Research Site
Uppsala, 75185
Research Site
Västerås, 721 89

Other trials in Sweden

Colombia13 sites

Research Site
Armenia, 630004
Research Site
Barranquilla, 80007
Research Site
Bogotá
Research Site
Bucaramanga
Research Site
Cali, 76001000
Research Site
Cali
Research Site
Cartagena, 130001
Research Site
Floridablanca, 681004
Research Site
Manizales, 17001
Research Site
Medellín, 05001000
Research Site
Medellín, 050015
Research Site
Medellín, 050034
Research Site
Medellín

Other trials in Colombia

Denmark13 sites

Research Site
Aarhus N, 8200
Research Site
Esbjerg, 6700
Research Site
Hjørring, 9800
Research Site
Hvidovre, 2650
Research Site
Købehhavn Ø, 2100
Research Site
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About this study

Official title: A Multinational, Randomised, Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Ticagrelor Twice Daily on the Incidence of Cardiovascular Death, Myocardial Infarction or Stroke in Patients With Type 2 Diabetes Mellitus (THEMIS - Effect of Ticagrelor on Health Outcomes in Diabetes Mellitus Patients Intervention Study).

The purpose of this study is to compare the effect of ticagrelor versus placebo in patients with Type 2 Diabetes Mellitus.

Read the detailed description

A multinational, randomised, double-blind, placebo-controlled phase IIIb trial to evaluate the effect of ticagrelor twice daily on the incidence of cardiovascular death, myocardial infarction or stroke in patients with type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2
Being tested: Ticagrelor 60 mg, Ticagrelor placebo
Keywords: Diabetes, Coronary artery disease, Outcome, Prevention, Antiplatelet
Medical subject headings: Diabetes Mellitus, Type 2, Diabetes Mellitus, Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ticagrelor 60 mgDrug
Also called Brilinta/Brilique
Ticagrelor 60 mg bd taken orally as tablets
Ticagrelor placeboDrug
Ticagrelor placebo bd taken orally as tablets

Study groups in NCT01991795
Study group	Role	What they receive
Ticagrelor 60 mg	Experimental	Initially ticagrelor 90 mg or corresponding placebo was the selected dose, but reduced to ticagrelor 60 mg or corresponding placebo in Clinical Study Protocol Amendment No 1. Receives: Drug: Ticagrelor 60 mg
Ticagrelor placebo	Placebo comparator	Initially ticagrelor 90 mg or corresponding placebo was the selected dose, but reduced to ticagrelor 60 mg or corresponding placebo in Clinical Study Protocol Amendment No 1. Receives: Drug: Ticagrelor placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Composite of Cardiovascular (CV) Death, MI or Stroke
Participants with Cardiovascular (CV) death, myocardial infarction (MI) or stroke. If no event, censoring occurs at the earliest of PACD, last endpoint assessment date and non-CV death date.
Measured: From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months.

Secondary outcomes (4)

CV Death
Participants with Cardiovascular (CV) death. If no event, censoring occurs at the earliest of PACD, last endpoint assessment date and non-CV death date.
Measured: From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months.
MI
Participants with myocardial infarction. If no event, censoring occurs at the earliest of primary analysis censoring date (PACD), last endpoint assessment date and death date
Measured: From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months.
Ischaemic Stroke
Participants with ischaemic stroke. If no event, censoring occurs at the earliest of PACD, last endpoint assessment date and death date.
Measured: From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months.
All-cause Death
Participants with all-cause death. If no event, censoring occurs at the earliest of PACD and last endpoint assessment date. Includes deaths based on publically available vital status data in patients who have withdrawn consent.
Measured: From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Feb 201425 Jan 2019

First posted25 Nov 2013 (estimated)
Study start10 Feb 2014
Primary completion25 Jan 2019
Study completion25 Jan 2019

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 (7)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
More trials run by AstraZenecaThe 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 19,271 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01991795
Sponsor's protocol ID: D513BC00001
Acronym: THEMIS
Status last verified: Mar 2020
First submitted: 18 Nov 2013
Last updated: 18 Mar 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Steg PG, Bhatt DL, Simon T, Fox K, Mehta SR, Harrington RA, Held C, Andersson M, Himmelmann A, Ridderstrale W, Leonsson-Zachrisson M, Liu Y, Opolski G, Zateyshchikov D, Ge J, Nicolau JC, Corbalan R, Cornel JH, Widimsky P, Leiter LA; THEMIS Steering Committee and Investigators. Ticagrelor in Patients with Stable Coronary Disease and Diabetes. N Engl J Med. 2019 Oct 3;381(14):1309-1320. doi: 10.1056/NEJMoa1908077. Epub 2019 Sep 1.
PubMed 31475798
Bhatt DL, Steg PG, Mehta SR, Leiter LA, Simon T, Fox K, Held C, Andersson M, Himmelmann A, Ridderstrale W, Chen J, Song Y, Diaz R, Goto S, James SK, Ray KK, Parkhomenko AN, Kosiborod MN, McGuire DK, Harrington RA; THEMIS Steering Committee and Investigators. Ticagrelor in patients with diabetes and stable coronary artery disease with a history of previous percutaneous coronary intervention (THEMIS-PCI): a phase 3, placebo-controlled, randomised trial. Lancet. 2019 Sep 28;394(10204):1169-1180. doi: 10.1016/S0140-6736(19)31887-2. Epub 2019 Sep 1.
PubMed 31484629
Bhatt DL, Fox K, Harrington RA, Leiter LA, Mehta SR, Simon T, Andersson M, Himmelmann A, Ridderstrale W, Held C, Steg PG; THEMIS Steering Committee. Rationale, design and baseline characteristics of the effect of ticagrelor on health outcomes in diabetes mellitus patients Intervention study. Clin Cardiol. 2019 May;42(5):498-505. doi: 10.1002/clc.23164. Epub 2019 Apr 9.
PubMed 30788847
Bonaca MP, Bhatt DL, Simon T, Fox KM, Mehta S, Harrington RA, Leiter LA, Capell WH, Held C, Himmelmann A, Ridderstrale W, Chen J, Lee JJ, Song Y, Andersson M, Prats J, Kosiborod M, McGuire DK, Steg PG. Limb Outcomes With Ticagrelor Plus Aspirin in Patients With Diabetes Mellitus and Atherosclerosis. J Am Coll Cardiol. 2024 Apr 30;83(17):1627-1636. doi: 10.1016/j.jacc.2024.03.377.
PubMed 38658101
Abtan J, Bhatt DL, Elbez Y, Ducrocq G, Goto S, Smith SC Jr, Ohman EM, Eagle KA, Fox K, Harrington RA, Leiter LA, Mehta SR, Simon T, Petrov I, Sinnaeve PR, Pais P, Lev E, Bueno H, Wilson P, Steg PG; REACH Registry Investigators. External applicability of the Effect of ticagrelor on Health Outcomes in diabEtes Mellitus patients Intervention Study (THEMIS) trial: An analysis of patients with diabetes and coronary artery disease in the REduction of Atherothrombosis for Continued Health (REACH) registry. Int J Cardiol. 2023 Jan 1;370:51-57. doi: 10.1016/j.ijcard.2022.10.132. Epub 2022 Oct 19.
PubMed 36270493
Wittbrodt E, Bhalla N, Sundell KA, Hunt P, Wong ND, Kuster M, Mellstrom C. Assessment of The High risk and unmEt Need in patients with CAD and type 2 diabetes (ATHENA): US healthcare resource use, cost, and burden of illness in a commercially insured population. J Diabetes Complications. 2021 Apr;35(4):107859. doi: 10.1016/j.jdiacomp.2021.107859. Epub 2021 Jan 20.
PubMed 33558152
Held P, Himmelmann A, Ditmarsch M. Ticagrelor for the treatment of atherosclerotic disease: insights from the PARTHENON clinical development program. Future Cardiol. 2016 Jul;12(4):405-18. doi: 10.2217/fca-2016-0028. Epub 2016 May 10.
PubMed 27160944

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multinational, Randomised, Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Ticagrelor Twice Daily on the Incidence of Cardiovascular Death, Myocardial Infarction or Stroke in Patients With Type 2 Diabetes Mellitus (THEMIS - Effect of Ticagrelor on Health Outcomes in Diabetes Mellitus Patients Intervention Study).
ClinicalTrials.gov ID: NCT01991795
Acronym / sponsor ID: THEMIS / D513BC00001
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes, Coronary artery disease, Outcome, Prevention, Antiplatelet
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 19,271 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 10 Feb 2014 (actual)
Primary completion: 25 Jan 2019 (actual)
Study completion: 25 Jan 2019 (actual)
First posted: 25 Nov 2013 (estimated)
Results: Posted 18 Mar 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to compare the effect of ticagrelor versus placebo in patients with Type 2 Diabetes Mellitus.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Ticagrelor 60 mg	Experimental	Drug: Ticagrelor 60 mgInitially ticagrelor 90 mg or corresponding placebo was the selected dose, but reduced to ticagrelor 60 mg or corresponding placebo in Clinical Study Protocol Amendment No 1.
Ticagrelor placebo	Placebo comparator	Drug: Ticagrelor placeboInitially ticagrelor 90 mg or corresponding placebo was the selected dose, but reduced to ticagrelor 60 mg or corresponding placebo in Clinical Study Protocol Amendment No 1.

Who may qualify

Ages: 50 to 130 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Men or women ≥50 years of age with type 2 diabetes mellitus on treatment with a glucose lowering medication since at least 6 months, and either documented coronary artery occlusive disease or previous revascularization of a coronary artery.

Key exclusion criteria (1 listed)

History of myocardial infarction or any stroke; planned treatment with agents inhibiting blood clotting; planned use of ASA/Aspirin at doses above 150 mg daily; planned coronary, cerebrovascular, or peripheral arterial revascularization; patients with known bleeding disorders and patients who need chronic oral anticoagulant therapy or chronic low-molecular-weight heparin; history of intracranial bleeding at any time, or a history of bleeding from the gastrointestinal tract within the last 6 months or a major surgery within the last 30 days; patients with known severe liver disease or with kidney failure requiring dialysis

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
Ticagrelor 60 mgAlso: Brilinta/BriliqueTicagrelor 60 mg bd taken orally as tablets	Drug	Ticagrelor 60 mg
Ticagrelor placeboTicagrelor placebo bd taken orally as tablets	Drug	Ticagrelor placebo

Primary outcome

Composite of Cardiovascular (CV) Death, MI or Stroke
Time frame: From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months.
Participants with Cardiovascular (CV) death, myocardial infarction (MI) or stroke. If no event, censoring occurs at the earliest of PACD, last endpoint assessment date and non-CV death date.

4 secondary outcomes

CV Death
Time frame: From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months.
MI
Time frame: From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months.
Ischaemic Stroke
Time frame: From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months.
All-cause Death
Time frame: From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months.

Results and safety

Results posted to the registry on 18 Mar 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ticagrelor 60 mg	9,645	9,496
Ticagrelor Placebo	9,626	9,503

Primary outcome: Composite of Cardiovascular (CV) Death, MI or Stroke

Time frame: From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months.. Number. Unit: Number of participants with event

Measure	Ticagrelor 60 mg n = 9619	Ticagrelor Placebo n = 9601
Value	736	818

Ticagrelor 60 mg vs Ticagrelor Placebo: Hazard Ratio (HR): 0.90 (95% CI 0.81 to 0.99), p = 0.0378, Regression, Cox

Population analysed: The population was the full analysis set, which included all randomised patients except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ticagrelor 60 mg	3,049 of 9,562 (31.9%)	1,951 of 9,562 (20.4%)	589 of 9,619
Ticagrelor Placebo	3,210 of 9,531 (33.7%)	610 of 9,531 (6.4%)	602 of 9,601

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 31475798Steg PG, Bhatt DL, Simon T, Fox K, Mehta SR, Harrington RA, Held C, Andersson M, Himmelmann A, Ridderstrale W, Leonsson-Zachrisson M, Liu Y, Opolski G, Zateyshchikov D, Ge J, Nicolau JC, Corbalan R, Cornel JH, Widimsky P, Leiter LA; THEMIS Steering Committee and Investigators. Ticagrelor in Patients with Stable Coronary Disease and Diabetes. N Engl J Med. 2019 Oct 3;381(14):1309-1320. doi: 10.1056/NEJMoa1908077. Epub 2019 Sep 1.
Background: PubMed 31484629Bhatt DL, Steg PG, Mehta SR, Leiter LA, Simon T, Fox K, Held C, Andersson M, Himmelmann A, Ridderstrale W, Chen J, Song Y, Diaz R, Goto S, James SK, Ray KK, Parkhomenko AN, Kosiborod MN, McGuire DK, Harrington RA; THEMIS Steering Committee and Investigators. Ticagrelor in patients with diabetes and stable coronary artery disease with a history of previous percutaneous coronary intervention (THEMIS-PCI): a phase 3, placebo-controlled, randomised trial. Lancet. 2019 Sep 28;394(10204):1169-1180. doi: 10.1016/S0140-6736(19)31887-2. Epub 2019 Sep 1.
Background: PubMed 30788847Bhatt DL, Fox K, Harrington RA, Leiter LA, Mehta SR, Simon T, Andersson M, Himmelmann A, Ridderstrale W, Held C, Steg PG; THEMIS Steering Committee. Rationale, design and baseline characteristics of the effect of ticagrelor on health outcomes in diabetes mellitus patients Intervention study. Clin Cardiol. 2019 May;42(5):498-505. doi: 10.1002/clc.23164. Epub 2019 Apr 9.
Derived from this study: PubMed 38658101Bonaca MP, Bhatt DL, Simon T, Fox KM, Mehta S, Harrington RA, Leiter LA, Capell WH, Held C, Himmelmann A, Ridderstrale W, Chen J, Lee JJ, Song Y, Andersson M, Prats J, Kosiborod M, McGuire DK, Steg PG. Limb Outcomes With Ticagrelor Plus Aspirin in Patients With Diabetes Mellitus and Atherosclerosis. J Am Coll Cardiol. 2024 Apr 30;83(17):1627-1636. doi: 10.1016/j.jacc.2024.03.377.
Derived from this study: PubMed 36270493Abtan J, Bhatt DL, Elbez Y, Ducrocq G, Goto S, Smith SC Jr, Ohman EM, Eagle KA, Fox K, Harrington RA, Leiter LA, Mehta SR, Simon T, Petrov I, Sinnaeve PR, Pais P, Lev E, Bueno H, Wilson P, Steg PG; REACH Registry Investigators. External applicability of the Effect of ticagrelor on Health Outcomes in diabEtes Mellitus patients Intervention Study (THEMIS) trial: An analysis of patients with diabetes and coronary artery disease in the REduction of Atherothrombosis for Continued Health (REACH) registry. Int J Cardiol. 2023 Jan 1;370:51-57. doi: 10.1016/j.ijcard.2022.10.132. Epub 2022 Oct 19.
Derived from this study: PubMed 33558152Wittbrodt E, Bhalla N, Sundell KA, Hunt P, Wong ND, Kuster M, Mellstrom C. Assessment of The High risk and unmEt Need in patients with CAD and type 2 diabetes (ATHENA): US healthcare resource use, cost, and burden of illness in a commercially insured population. J Diabetes Complications. 2021 Apr;35(4):107859. doi: 10.1016/j.jdiacomp.2021.107859. Epub 2021 Jan 20.
Derived from this study: PubMed 27160944Held P, Himmelmann A, Ditmarsch M. Ticagrelor for the treatment of atherosclerotic disease: insights from the PARTHENON clinical development program. Future Cardiol. 2016 Jul;12(4):405-18. doi: 10.2217/fca-2016-0028. Epub 2016 May 10.
D513BC00001\_CSP\_redactedLink provided by the sponsor.
D513BC00001\_SAP\_redactedLink 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.

Philippe Gabriel Steg, MD principal investigator

Hôpital Bichat-Claude Bernard 46 Rue Henri Huchard, Paris

Deepak L. Bhatt, MD principal investigator

Brigham and Women's Hospital75 Francis Street, Boston

1,237 sites in 43 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ticagrelor 60 mg in people with Diabetes Mellitus, Type 2, run by AstraZeneca at 1,237 sites in 43 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 1 inclusion and 1 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 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1,237 sites in United States, Poland, Russia, Canada, Japan and 38 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 18 Mar 2020). 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?

Composite of Cardiovascular (CV) Death, MI or Stroke (time frame: From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months.). 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 NCT01991795, which also lists 7 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 18 Mar 2020.