Acute Coronary SyndromePhase 3TRILOGY ACSNCT00699998
A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome Subjects
A Phase 3 study testing Clopidogrel, Prasugrel and Commercially-available Aspirin in people with Acute Coronary Syndrome, run by Eli Lilly and Company at 688 sites in 53 countries.
Trial summary
This study will evaluate the relative efficacy and safety of prasugrel and clopidogrel in a medically managed Unstable Angina/Non-ST-Elevation Myocardial Infarction (UA/NSTEMI) acute coronary syndrome (ACS) population (that is, patients who are not managed with acute coronary revascularization). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Clopidogrel, Prasugrel and Commercially-available Aspirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9,326 participants
- Where
- 688 sitesin 53 countries
- Study dates
- Jun 2008to Apr 2012
- Phase
- Phase 3
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have had a Unstable Angina/Non-ST-Elevation Myocardial Infarction (UA/NSTEMI) index event within 10 days prior to randomization
- Had a medical management strategy decision made with reasonable certainty that neither percutaneous coronary intervention (PCI) nor coronary artery bypass graft (CABG) is planned for treatment of the index event
- Had at least 1 of 4 specified high-risk features at the time of the UA/NSTEMI event
Who cannot join
- Decision for medical management greater than 72 hours after onset of index event without commercial clopidogrel treatment within 72 hours following onset of the index event.
- Insignificant coronary artery disease (CAD) on coronary angiography if performed for Index Event (absence of greater than or equal to 30% stenosis in at least one native vessel)
- Previous or planned PCI or CABG as treatment for the index event
- PCI/CABG within previous 30 days
- ST-segment elevation myocardial infarction (STEMI) as the index event
- Cardiogenic shock, Refractory ventricular arrhythmias, New York Heart Association (NYHA) Class IV congestive heart failure (CHF) within the previous 24 hours
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- History of ischemic or hemorrhagic stroke, transient ischemic attack (TIA), Intracranial neoplasm, arteriovenous malformation, or aneurysm
- History of spontaneous gastrointestinal (GI) or non-GI bleeding requiring hospitalization for treatment, unless definitive treatment has occurred and there is low likelihood of recurrence
- Hemodialysis or peritoneal dialysis
Trial locations and contacts
688 sites in 53 countries.
688 sites in 53 countries
United States165 sites
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Abington, Pennsylvania, 19001
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Alexandria, Louisiana, 71301
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Amarillo, Texas, 79106
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American Fork, Utah, 84003
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Ames, Iowa, 50010
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Anaheim, California, 92801
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Anderson, Indiana, 46011
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Atlanta, Georgia, 30342
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Atlantis, Florida, 33462
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Austin, Texas, 78745
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Aventura, Florida, 33180
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Baltimore, Maryland, 21287
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Banning, California, 92220
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Baton Rouge, Louisiana, 70808
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Bay City, Michigan, 48706
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Bellflower, California, 90706
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Bethlehem, Pennsylvania, 18015
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Birmingham, Alabama, 35233
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Boston, Massachusetts, 02135
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Boynton Beach, Florida, 33472
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Brandon, Florida, 33511
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Bridgewater, New Jersey, 08807
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Brooklyn, New York, 11220
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Buffalo, New York, 14215
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Burlington, Wisconsin, 53105
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Chambersburg, Pennsylvania, 17201
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Chapel Hill, North Carolina, 27599
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Charleston, South Carolina, 29425
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Charlotte, North Carolina, 28204
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Charlottesville, Virginia, 22908
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Chattanooga, Tennessee, 37404
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Cherry Hill, New Jersey, 08002
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Cincinnati, Ohio, 45220
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Clarks Summit, Pennsylvania, 18411
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Cleveland, Ohio, 44106
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Colorado Springs, Colorado, 80909
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Columbia, Missouri, 65201
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Corpus Christi, Texas, 78404
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Covington, Georgia, 30014
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Covington, Louisiana, 70433
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Danville, Virginia, 24541
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Decatur, Georgia, 30033
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Deerfield Beach, Florida, 33442
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Denver, Colorado, 80218
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Doylestown, Pennsylvania, 18901
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Edinburg, Texas, 78539
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Elizabeth City, North Carolina, 27909
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Elkhart, Indiana, 46514
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Erie, Pennsylvania, 16502
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Fall River, Massachusetts, 02720
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Flemington, New Jersey, 08822
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Flint, Michigan, 48532
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Flushing, New York, 11355
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Fort Sam Houston, Texas, 78234
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Fort Smith, Arkansas, 72917
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Gastonia, North Carolina, 28054
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Germantown, Tennessee, 38138
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Glendale, Arizona, 85306
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Greensburg, Pennsylvania, 15601
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Hammond, Indiana, 46320
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Harrisburg, Pennsylvania, 17110
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Healdsburg, California, 95448
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Hendersonville, Tennessee, 37075
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Hickory, North Carolina, 28601
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Hillsboro, Oregon, 97123
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Hopewell, Virginia, 23860
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Houston, Texas, 77089
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Hudson, Florida, 34667
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Huntsville, Alabama, 35801
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Indianapolis, Indiana, 46250
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Jackson, Tennessee, 38301
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Johnson City, Tennessee, 37601
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Kalispell, Montana, 59901
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Kansas City, Missouri, 64111
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Knoxville, Tennessee, 37917
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Lackland Air Force Base, Texas, 78236
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Lake Charles, Louisiana, 70601
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Lake Ridge, Virginia, 22192
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Lakeland, Florida, 33805
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Lancaster, California, 93534
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Las Vegas, Nevada, 89148
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Lenoir, North Carolina, 28645
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Lexington, Tennessee, 38351
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Long Beach, California, 90822
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Los Angeles, California, 90027
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Louisville, Kentucky, 40207
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Loveland, Colorado, 80538
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Manassas, Virginia, 20109
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Mansfield, Ohio, 44906
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Mather, California, 95655
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Matthews, North Carolina, 28105
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Melbourne, Florida, 32901
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Melrose Park, Illinois, 60160
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Memphis, Tennessee, 38120
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Miami, Florida, 33176
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Milwaukee, Wisconsin, 53215
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Minneapolis, Minnesota, 55417
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Muncie, Indiana, 47303
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Muskogee, Oklahoma, 74401
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Nashua, New Hampshire, 03060
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Natchitoches, Louisiana, 71457
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New Hartford, New York, 13413
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New Orleans, Louisiana, 70112
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New York, New York, 10016
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Newport Beach, California, 92663
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Newport News, Virginia, 23601
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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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Orlando, Florida, 32803
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Ormond Beach, Florida, 32174
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Palo Alto, California, 94304
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Panama City, Florida, 32401
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Pensacola, Florida, 32501
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Peoria, Illinois, 61614
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Picayune, Mississippi, 39466
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Pinehurst, North Carolina, 28374
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Pittsburgh, Pennsylvania, 15240
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Port Charlotte, Florida, 33952
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Portland, Oregon, 97220
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Pottstown, Pennsylvania, 19464
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Rapid City, South Dakota, 57701
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Richmond, Virginia, 23298
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Ridgewood, New Jersey, 07652
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Riverdale, Georgia, 30274
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Roanoke, Virginia, 24014
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Rock Hill, South Carolina, 29732
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Rock Island, Illinois, 61201
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Sacramento, California, 95817
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Salisbury, Maryland, 21804
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Salisbury, North Carolina, 28144
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Salt Lake City, Utah, 84124
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San Antonio, Texas, 78201
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San Diego, California, 92123
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Sanford, North Carolina, 27330
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Sarasota, Florida, 34232
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Savannah, Georgia, 31405
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Sayre, Pennsylvania, 18840
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Seattle, Washington, 98122
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Sellersville, Pennsylvania, 18960
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Sioux Falls, South Dakota, 57104
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Spokane, Washington, 99204
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St Louis, Missouri, 63128
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Statesville, North Carolina, 28677
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Sylmar, California, 91342
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Syracuse, New York, 13210
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Tacoma, Washington, 98405
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Tallahassee, Florida, 32308
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Tampa, Florida, 33613
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The Bronx, New York, 10461
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Toledo, Ohio, 43608
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Trinity, Florida, 34655
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Tucson, Arizona, 85724
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Tulsa, Oklahoma, 74104
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Valparaiso, Indiana, 46383
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Victoria, Texas, 77901
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Washington D.C., District of Columbia, 20422
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West Chester, Pennsylvania, 19380
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West Palm Beach, Florida, 33401
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Wheat Ridge, Colorado, 80033
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Wilmington, North Carolina, 28403
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Winston-Salem, North Carolina, 27157
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Wormleysburg, Pennsylvania, 17043
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Yuba City, California, 95991
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Zanesville, Ohio, 43701
India39 sites
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Ahmedabad, 382 428
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Anand, 388325
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Aurangabad, 431001
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Bangalore, 560034
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Bārāmati, 413102
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Bikaner, 334003
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Calicut, 673004
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Chidambaram, 608002
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Coimbatore, 641004
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Ernākulam, 683577
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Guntur, 522001
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Gūrgaon, 122001
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Hyderabaad, 500001
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Indore, 452018
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Jaipur, 302017
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Jalandhar, 144008
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Kochi, 683572
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Kolkata, 700091
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Kottayam, 686016
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Lucknow, 226003
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Madurai, 625020
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Mumbai, 400012
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Mysore, 570004
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Nagpur, 440033
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Nashik, 422005
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New Delhi, 110015
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Patiāla, 147001
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Pune, 411033
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Sāket, 110017
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Secunderabad, 500 003
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Shivamogga, 577201
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Solapur, 413003
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Surat, 395007
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Thrissur, 680002
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Tirupati, 517 507
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Trivandrum, 695002
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Vadodara, 390015
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Vijayawada, 520008
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Visakhapatnam, 530 003
United Kingdom30 sites
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Birmingham, West Midlands, B75 7RR
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Bradford, West Yorkshire, BD9 6RJ
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Brighton, East Sussex, BN2 5BE
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Chesterfield, Derbyshire, S44 5BL
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Colchester, Essex, C04 5JL
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Cottingham, East Yorkshire, HU16 5JQ
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Dudley, West Midlands, DY1 2HQ
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Dundee, Tays, DD1 9SY
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Durham, County Durham, DH1 5TW
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Lincoln, Lincolnshire, LN2 5QY
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Livingston, West Lothian, EH54 6PP
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London, Greater London, SE13 6LH
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Metropolitan Borough of Wirral, Merseyside, CH49 5PE
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Newport, Gwent, NP20 2UB
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Northampton, NN1 5BD
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Nottingham, Nottinghamshire, NG5 1PD
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Nuneaton, Warwickshire, CV10 7BL
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Orpington, Kent, BR6 8ND
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Plymouth, Devon, PL6 8DH
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Portsmouth, Hampshire, P06 3LY
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Romford, Essex, RM7 0AG
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Southall, Greater London, UB1 3HW
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Stockton-on-Tees, Cleveland, TS19 8PE
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Sunderland, Sunderland, SR4 7TP
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Torquay, Cnwll, TQ2 7AA
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Warwick, Warwickshire, CV34 5BW
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West Bromwich, West Midlands, B71 4HJ
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Wolverhampton, West Midlands, WV10 0QP
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Yeovil, Somerset, BA21 4AT
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York, North Yorkshire, YO31 8HE
Brazil27 sites
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Aracaju, 49015-400
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Belo Horizonte, 30380-090
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Blumenau, 89010-500
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Brasília, 70658-700
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Campina Grande do Sul, 83430-000
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Campinas, 13010-001
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Campo Grande, 79080-190
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Caxias do Sul, 95070560
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Curitiba, 80010-030
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Dois Lajeados, 95900-000
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Goiânia, 74223-130
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Maceió, 57021-500
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Maringá, 87015-290
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Passo Fundo, 99010-080
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Piracicaba, 13405-126
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Porto Alegre, 91350-200
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Recife, 52051-380
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Ribeirão Preto, 14048-900
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Rio de Janeiro, 21041-030
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Salvador, 41144900
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Santo André, 09190-610
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São Caetano do Sul, 09540-400
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São José, 88103-460
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Sao Jose Rio Preto, 15090-000
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São Paulo, 05017000
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Uberlândia, 38400-368
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Votuporanga, 15500-003
Italy24 sites
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Albano Laziale, 00041
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Ascoli Piceno, 63100
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Bari, 70124
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Bergamo, 24128
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Brescia, 25127
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Caserta, 81100
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Forlì, 47100
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Lecco, 23900
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Legnago, 37045
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Legnano, 20025
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Milan, 20162
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Novara, 28100
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Parma, 43100
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Perugia, 06156
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Pescara, 65124
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Reggio Emilia, 42100
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Rimini, 47900
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Rome, 00161
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San Daniele del Friuli, 33038
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Santa Maria Capua Vetere, 81055
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Saronno, 21047
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Sorrento, 80067
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Terni, 5100
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Trieste, 34142
China22 sites
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Beijing, 100032
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Beijing, 100730
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Changsha, 410013
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Fuzhou, 350001
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Guangzhou, 510120
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Hangzhou, 310013
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Harbin, 150001
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Jiangsu, 210009
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Nanchang
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Nanjing, 210008
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Shanghai, 200032
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Shaoguan, 512026
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Shengyang, 110004
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Shenyang, 110001
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Shijiazhuang, 050050
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Suzhou, 215004
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Wenzhou, 325027
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Wuhan, 430030
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Wuhan, 430060
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Xi'an, 710061
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Xuzhou, 221006
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Zhengzhou, 450003
Poland22 sites
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Bydgoszcz, 85-826
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Elblag, 02-300
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Gdansk, 80-345
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Katowice, 40-635
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Koszalin, 75-581
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Krakow, 31-501
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Kutno, 99-300
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Lodz, 94-255
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Lubin, 59-301
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Lublin, 20-954
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Myślenice, 32-400
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Nowy Sącz, 33-300
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Oława, 55-200
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Piotrkow Trybunalski, 97-300
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Puławy, 24-100
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Ruda Śląska, 41-703
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Skierniewice, 96-100
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Szczecin, 71-531
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Wałbrzych, 58-309
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Warsaw, 04-439
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Wejherowo, 84-200
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Wroclaw, 51-124
Argentina18 sites
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Bahía Blanca, B8001DDU
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Buenos Aires, 1094
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Caba, C1180AAX
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Concordia, E3202BQF
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Córdoba, X5000JHQ
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Corrientes, 3400
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Formosa, 3606
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Godoy Cruz, 5501
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La Plata, B1900AVS
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Mar del Plata, B7600FZD
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Morón, B1708KCH
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Rosario, S2002KDS
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Salta, A4402DTC
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San Luis, D5702JRS
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San Miguel de Tucumán, T4000NIL
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Santa Fe, S3000FUJ
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Villa Cabrera, S5009BSN
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Villa María, X5900JKA
France18 sites
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Angers, 49933
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Arras, 62000
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Besançon, 25030
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Cambrai, 59407
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Chartres, 28018
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Dijon, 21079
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Douai, 59507
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La Roche-sur-Yon, 85025
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Lagny-sur-Marne, 77405
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Nantes, 44277
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Nice, 06002
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Paris, 75015
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Pessac, 33604
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Poitiers, 86021
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Strasbourg, 67091
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Toulouse, 31059
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Valenciennes, 59322
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Vandœuvre-lès-Nancy, 54511
Netherlands18 sites
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Alkmaar, 1815 JD
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Almelo, 7609 PP
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Amsterdam, 1091AC
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Apeldoorn, 7334 DZ
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Beverwijk, 1942 LE
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Blaricum, 1261 AN
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Delft, 2625AD
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Ede, 6716 RP
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Eindhoven, 5623 EJ
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Gouda, 2803 HH
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Hoorn, 1625 HV
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Leeuwarden, 8934 AD
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Leiden, 2334 CK
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Leiderdorp, 2353 GA
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Meppel, 7943 KA
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Oss, 5342 BT
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Roosendaal, 4708 AE
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Venlo, 5912 BL
Ukraine17 sites
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Cherkasy, 18009
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Dnipropetrovsk, 49006
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Donetsk, 83114
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Ivano-Frankivsk, 76018
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Kharkiv, 61176
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Kiev, 02660
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Kryvyy Rig, 50031
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Kyiv, 3115
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Luhansk, 91045
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Lutsk, 43024
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Lviv, 79015
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Mykolayiv, 54003
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Odesa, 65025
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Poltava, 36038
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Simferopol, 95026
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Vinnytsia, 21029
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Zaporizhzhya, 69000
Russia15 sites
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Arkhangelsk, 163045
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Gatchina, 188300
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Kazan', 420029
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Kemerovo, 650002
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Krasnoyarsk, 660062
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Moscow, 127644
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Nizhny Novgorod, 603005
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Novokuznetsk, 654057
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Novosibirsk, 630090
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Omsk, 644018
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Rostov-on-Don, 344068
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Saint Petersburg, 197110
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Saratov, 410028
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Tomsk, 634012
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Tyumen, 625000
Canada14 sites
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Ajax, Ontario, L1S 2J5
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Burlington, Ontario, L7M 4Y1
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Cambridge, Ontario, N1R 7R1
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Campbell River, British Columbia, V9W 5Y4
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Edmonton, Alberta, T6K 4C1
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Greater Sudbury, Ontario, P3E 2N8
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Halifax, Nova Scotia, B3H 3A7
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London, Ontario, N6A 5A5
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Montreal, Quebec, H3G 1A4
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Oshawa, Ontario, L1H 1B9
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Sainte-Foy, Quebec, G1V 4G5
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Sarnia, Ontario, N7T 4R9
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Scarborough Village, Ontario, M1E 5E9
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St. John's, Newfoundland and Labrador, A1B 3V6
Israel14 sites
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Afula, 18101
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Ashkelon, 78278
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Beersheba, 84101
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Eilat, 88104
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Haifa, 31096
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Jerusalem, 91240
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Kfar Saba, 44281
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Nahariya, 22100
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Nazareth, 16100
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Rehovot, 76100
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Tel Aviv, 64239
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Tel Litwinsky, 52621
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Tiberias, 15208
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Tzfat, 13100
Turkey (Türkiye)13 sites
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Adana, 1330
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Ankara, 06800
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Bolu, 14280
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Bursa, 16059
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Edirne, 22030
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Erzurum, 25050
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Isparta, 32100
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Istanbul, 34300
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Kirikkale, 71100
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Kocaeli, 41380
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Konya, 42075
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Samsun, 55139
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Trabzon, 61080
Germany12 sites
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Bad Nauheim, 61231
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Cologne, 50968
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Darmstadt, 64283
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Dortmund, 44137
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Frankfurt, 65929
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Halle, 06120
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Idar-Oberstein, 55743
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Leipzig, 04289
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Mainz, 55131
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Mannheim, 68167
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Stuttgart, 70376
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Tübingen, 72076
Australia11 sites
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Bedford Park, South Australia, 5042
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Coffs Harbour, New South Wales, 2450
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Elizabeth Vale, South Australia, 5112
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Herston, Queensland, 4029
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Hobart, Tasmania, 7000
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Lismore, New South Wales, 2480
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Nambour, Queensland, 4560
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Newcastle, New South Wales, 2305
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Redcliffe, Queensland, 4020
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Southport, Queensland, 4215
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Wollongong, New South Wales, 2500
Hungary11 sites
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Baja, 6500
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Békéscsaba, 5601
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Budapest, 1125
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Kalocsa, 6300
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Kecskemét, 6000
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Komárom, 2921
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Miskolc, H-3529
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Sátoraljaújhely, H-3980
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Sopron, 9400
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Szekszárd, 7100
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Zalaegerszeg, 8900
Romania11 sites
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Bacau, 600114
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Baia Mare, 430110
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Brăila, 810249
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Brasov, 500326
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Bucharest
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Buzău, 120144
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Cluj-Napoca, 400006
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Focşani, 620034
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Piteşti, 110084
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Suceava, 7202237
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Targoviste, 130083
Bulgaria10 sites
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Dimitrovgrad, 6400
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Haskovo, 6300
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Kazanlak, 6100
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Kyustendil, 2500
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Pazardzhik, 4400
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Pleven, 5800
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Plovdiv, 4002
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Rousse, 7002
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Sofia, 1606
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Varna, 9010
Croatia10 sites
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Dubrovnik, 20000
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Karlovac, 47000
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Koprivnica, 48000
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Krapinske Toplice, 49217
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Rijeka, 51 000
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Slavonski Brod, 35 000
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Split, 21000
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Varaždin, 42 000
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Zadar, 23000
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Zagreb, 10000
Czechia10 sites
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Děčín, 405 99
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Frýdek-Místek, 738 18
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Hradec Králové, 500 05
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Karlovy Vary, 360 66
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Kroměříž, 767 55
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Liberec, 460 03
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Nový Jičín, 74101
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Pardubice, 532 03
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Prague, 140 21
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Zlín, 76275
Mexico10 sites
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Aguascalientes, 20230
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Culiacán, 80270
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Durango, 340000
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Jalisco, 44210
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León, 37660
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Monterrey, 64020
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Puebla City, 72490
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Querétaro, 76180
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San Luis Potosí City, 78240
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Tijuana, 22500
Philippines10 sites
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Cagayan de de Oro, 9000
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Cavite City, 4114
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Davao City, 8000
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Iloilo City, 5000
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Manila, 1000
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Marikina City
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Metro Manila, 1503
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Pasig, 1605
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Quezon City, 1102
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Quezon City, 1110
South Korea10 sites
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Busan, 614-735
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Daegu, 705-718
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Daejeon, 302-718
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Gangwon-Do, 220-701
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Gwangju, 501-757
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Incheon, 405-760
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Jeonju, 561-712
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Jinju, 660-702
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Seoul, 120-752
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Ulsan, 682-714
Malaysia9 sites
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Cheras, Kuala Lumpur, 56000
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Johor Bahru, 80100
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Kelantan, 16150
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Kuala Lumpur, 59100
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Kuala Selangor, 43300
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Kuantan Pahang, 25100
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Perak, 30990
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Sarawak, 93586
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Taiping Perak, 34000
South Africa9 sites
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Alberton, 1449
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Bloemfontein, 9301
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Cape Town, 7405
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Durban, 4071
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George, 6529
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Johannesburg, 2193
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Parktown West, 2193
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Somerset West, 7129
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Worcester, 6850
Portugal8 sites
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Aveiro, 3814-501
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Carnaxide, 2790-134
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Coimbra, 3000-075
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Leiria, 2410-197
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Ponta Delgada, 9500-370
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Santarém, 2005-177
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Setúbal, 2910-446
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Vila Franca de Xira, 5000-508
Slovakia8 sites
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Bratislava, 83348
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Levice, 934 01
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Martin, 03601
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Nitra, 95001
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Nové Zámky, 94034
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Prešov, 08181
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Ružomberok, 03426
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Žilina, 010 01
Spain8 sites
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Barcelona, 08227
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Girona, 17600
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Málaga, 29010
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Palma de Mallorca, 07198
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Reus, 43201
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San Boi de Llobregat, 08830
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Seville, 41008
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Valencia, 46014
Chile7 sites
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La Serena
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Osorno, 5290000
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Puente Alto, 8207257
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Rancagua
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Santiago, 8900085
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Temuco, 478-1151
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Viña del Mar
Greece7 sites
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Athens, 16673
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Haidari/Athens, 12462
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Kallithea, 17674
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Magoula, 19600
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Pátrai, 26504
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Rhodes, 85100
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Trikala, 42100
Tunisia7 sites
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La Marsa, 2046
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Menzel Bourguiba, 7050
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Monastir, 5000
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Sfax, 3051
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Sousse, 4054
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Tunis, 2070
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Tunis Monfleury, 1008
Colombia6 sites
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Armenia-Quindio
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Barranquilla
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Bogotá
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Cali
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Floridablanca
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Medellín
Thailand6 sites
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Bangkok, 10700
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Chiang Mai, 50200
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Khon Kaen, 40002
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Nakhon Ratchasima, 30000
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Pathum Thani, 12120
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Udon Thani, 41000
Belgium5 sites
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Brussels, 1200
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Huy, 4500
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Liège, 4000
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Mol, 2400
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Overpelt, 3900
Egypt5 sites
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Alexandria, 21131
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Beni Sweif
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Cairo
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Ismailia
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Menoufiya
Serbia5 sites
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Belgrade, 11040
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Kragujevac, 34000
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Niš, 18000
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Niška Banja, 18205
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Zemun, 11080
Lithuania4 sites
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Kaunas, LT-50009
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Klaipėda, 92288
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Šiauliai, 73231
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Vilnius, LT-08661
New Zealand4 sites
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Auckland, 0622
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Christchurch, 8011
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Nelson, 7010
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Wellington, 6022
Peru4 sites
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Arequipa
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Callao
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Cuzco
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Lima, Lima 29
Denmark3 sites
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Copenhagen, 2300
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Copenhagen, 2400
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Hellerup, 2900
Panama3 sites
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Coclé
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David
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Panama City
Puerto Rico3 sites
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Caguas, 00725
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Mayagüez, 00680
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San Juan, 00921-3201
Sweden3 sites
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Bollnäs, 82181
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Karlstad, 65185
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Lund, 22241
Austria2 sites
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Feldkirch, 6807
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Vienna, 1100
Ireland2 sites
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Dublin
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Galway
Malta2 sites
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Gozo, VCT102
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Msida, 2090
Switzerland2 sites
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Bellinzona, CH-6500
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Winterthur, 8401
Taiwan2 sites
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Kaohsiung City, 80756
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Taipei, 220
Costa Rica1 site
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San José
Finland1 site
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Jyväskylä, 40620
Singapore1 site
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Singapore, 119074
About this study
Official title: A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome Subjects With Unstable Angina/Non-ST-Elevation Myocardial Infarction Who Are Medically Managed
This study will evaluate the relative efficacy and safety of prasugrel and clopidogrel in a medically managed Unstable Angina/Non-ST-Elevation Myocardial Infarction (UA/NSTEMI) acute coronary syndrome (ACS) population (that is, patients who are not managed with acute coronary revascularization).
Read the detailed description
Based upon the significant number of subjects with UA/NSTEMI ACS who are managed medically and their high risk for future cardiovascular events, further exploration of novel treatment strategies for this population, who are under-represented in large clinical trials, is warranted. Potential subjects will be those with a recent UA/NSTEMI event who are to be medically managed. Eligibility for this study will be determined by both the timing of the medical management decision and by prior commercial clopidogrel treatment at the time of randomization. The TaRgeted platelet Inhibition to cLarify the Optimal strateGy to medicallY manage Acute Coronary Syndromes (TRILOGY ACS) Study will assess the efficacy and safety of prasugrel and aspirin compared to the current standard of care, clopidogrel and aspirin, for long-term treatment of medically managed UA/NSTEMI ACS subjects.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Clopidogrel, Prasugrel, Commercially-available Aspirin
- Keywords
- ACS
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClopidogrelDrug
300 milligrams (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study
PrasugrelDrug
Also called LY640315, Effient, Efient, CS-747
30 milligrams (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight and age), oral, once daily as maintenance dose through end of study
Commercially-available AspirinDrug
Low-dose aspirin, oral, as prescribed by physician through end of study
| Study group | Role | What they receive |
|---|---|---|
| Prasugrel | Experimental | Prasugrel and Low-dose Commercially-available Aspirin Receives: Drug: Prasugrel; Drug: Commercially-available Aspirin |
| Clopidogrel | Active comparator | Clopidogrel and Low-Dose Commercially-available Aspirin Receives: Drug: Clopidogrel; Drug: Commercially-available Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With a Composite Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Stroke
The percentage of participants is the total number of participants experiencing a CV death, nonfatal MI, or nonfatal stroke divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
Measured: Randomization through end of study (30-month visit)
Secondary outcomes (9)
Percentage of Participants With a Composite Endpoint of CV Death and MI
The percentage of participants is the total number of participants experiencing a CV death or nonfatal MI divided by number of participants in the treatment arm. Endpoint events were adjudicated by the Clinical Endpoint Committee.
Measured: Randomization through end of study (30-month visit)
Percentage of Participants With a Composite Endpoint of CV Death, MI, Stroke, or Re-hospitalization for Recurrent Unstable Angina (UA)
The percentage of participants is the total number of participants experiencing a CV death, nonfatal MI, nonfatal stroke or re-hospitalization for a recurrent UA divided by number of participants in the treatment arm. Endpoints events were adjudicated by the Clinical Endpoint Committee.
Measured: Randomization through end of study (30-month visit)
Percentage of Participants With a Composite Endpoint of All-cause Death, MI, or Stroke
The percentage of participants is the total number of participants experiencing an all-cause death, nonfatal MI, or nonfatal stroke divided by number of participants in the treatment arm. Endpoint events were adjudicated by the Clinical Endpoint Committee.
Measured: Randomization through end of study (30-month visit)
Platelet Aggregation Measures
Platelet aggregation was measured by as measured by Accumetrics Verify Now™ P2Y12. Results were reported in P2Y12 Reaction Units (PRU). PRU represents the rate and extent of adenosine (ADP)-stimulated platelet aggregation. Lower values indicate greater P2Y12 platelet inhibition and lower platelet activity and aggregation. ANCOVA Model was used and values were corrected for treatment + baseline value + clopidogrel status at randomization.
Measured: Day 30 and 12 Months
Biomarker Measurements of Inflammation/Hemodynamic Stress: Brain Natriuretic Peptide (BNP)
Brain natriuretic peptide (BNP) is secreted by the ventricles of the heart in response to hemodynamic stress and is a biomarker associated with increased CV risk. Results are presented as geometric least squares means (Geometric LS means). Geometric LS means were adjusted for treatment + baseline value + clopidogrel status at randomization.
Measured: Day 30 and 6 Months
Biomarker Measurements of Inflammation/Hemodynamic Stress: C-Reactive Protein (CRP)
C-Reactive Protein (CRP) is a biomarker associated with inflammation and increased CV risk. Results are presented as geometric least squares means (Geometric LS means). Geometric LS means were adjusted for treatment + baseline value + clopidogrel status at randomization.
Measured: Day 30 and Month 6
Genotyping Related to Drug Metabolism
Variation in the genes encoding the cytochrome P450 (CYP) enzymes (CYP2C19) can reduce the ability to metabolize clopidogrel and a reduced platelet response and have been associated with increased rates of CV events including CV death. Participants were classified as extensive metabolizers (EM); reduced metabolizers (RM); or unknown (UNK) metabolizers based on their CYP2C19 genotype. Possible extensive metabolizer (EM) phenotypes include EM=extensive metabolizer, UM=ultra-rapid metabolizer, and EM (non-UM) that are not UM. Possible reduced metabolizer (RM) phenotypes include IM=intermediate metabolizer and PM=poor metabolizer. Genotypes associated with each predicted phenotype are presented; predicted phenotype is presented first followed by the genotype. Percentage=(number of participants with the predicted phenotype and genotype divided by the total number of participants per arm) multiplied by 100.
Measured: Baseline
Economic and Quality of Life Outcomes
Seattle Angina Questionnaire (SAQ) is a validated, disease-specific questionnaire containing 11 questions (Q) yielding 5 summary scales related to angina: physical limitations, angina stability, angina frequency, treatment satisfaction and disease perception. In this study only angina frequency and the physical limitations scales were assessed. Anginal Frequency was assessed using Q3 and Q4 which consists of a Likert scale ranging from 1 to 6 (higher values equals better quality of life) to assess how often a patient is having symptoms now. Physical limitations was assessed using Q1 which contains 9 items each assessed via Likert scale ranging from 1 to 6 (higher values equals better quality of life) to assess how much a participant's condition is hampering their ability to do what they want to do. Scale scores are transformed to a 0-100 by subtracting the lowest possible score, dividing by the range of the scale, and multiplying by 100. Higher values equal better quality of life.
Measured: Baseline and follow-up (24 months)
Summary of All Deaths
All deaths, regardless of possible relatedness, with the exception of 1 event, were adjudicated by the Clinical Endpoint Committee (CEC) and are reported in this table. The 1 event which was not adjudicated was a result of the revocation of consent by the participant prior to their death. Deaths possibly related to study drug in the opinion of the investigator are also contained in the Serious Adverse Event (SAE) module.
Measured: Randomization through end of study (30-month visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionApr 2012
- Study completionApr 2012
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 (24)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe 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
- 9,326 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Daiichi Sankyo Co., Ltd., Duke Clinical Research Institute
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00699998
- Sponsor's protocol ID
- 11058
- Other IDs
- H7T-MC-TABY(b)
- Acronym
- TRILOGY ACS
- Status last verified
- Mar 2013
- First submitted
- 16 Jun 2008
- Last updated
- 7 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.
PubMed 35224730Marquis-Gravel G, Neely ML, Valgimigli M, Costa F, Van Klaveren D, Altner R, Bhatt DL, Armstrong PW, Fox KAA, White HD, Ohman EM, Roe MT. Long-Term Bleeding Risk Prediction with Dual Antiplatelet Therapy After Acute Coronary Syndromes Treated Without Revascularization. Circ Cardiovasc Qual Outcomes. 2020 Sep;13(9):e006582. doi: 10.1161/CIRCOUTCOMES.120.006582. Epub 2020 Aug 31.
PubMed 32862694Kaul P, Alexander KP, Ohman EM, Savu A, Roe MT, Goodman SG, Fox KA, White HD, Prabhakaran D, Hochman JS, Clemmensen P, Armstrong PW. Sex And Prognostic Significance of Self-Reported Frailty in Non-ST-Segment Elevation Acute Coronary Syndromes: Insights From the TRILOGY ACS Trial. Can J Cardiol. 2019 Apr;35(4):430-437. doi: 10.1016/j.cjca.2018.12.035. Epub 2018 Dec 31.
PubMed 30935633Fanaroff AC, Cyr D, Neely ML, Bakal J, White HD, Fox KAA, Armstrong PW, Lopes RD, Ohman EM, Roe MT. Days Alive and Out of Hospital: Exploring a Patient-Centered, Pragmatic Outcome in a Clinical Trial of Patients With Acute Coronary Syndromes. Circ Cardiovasc Qual Outcomes. 2018 Dec;11(12):e004755. doi: 10.1161/CIRCOUTCOMES.118.004755.
PubMed 30562068Inohara T, Pieper K, Wojdyla DM, Patel MR, Jones WS, Tricoci P, Mahaffey KW, James SK, Alexander JH, Lopes RD, Wallentin L, Ohman EM, Roe MT, Vemulapalli S. Incidence, timing, and type of first and recurrent ischemic events in patients with and without peripheral artery disease after an acute coronary syndrome. Am Heart J. 2018 Jul;201:25-32. doi: 10.1016/j.ahj.2018.03.013. Epub 2018 Mar 28.
PubMed 29910052Chan MY, Neely ML, Roe MT, Goodman SG, Erlinge D, Cornel JH, Winters KJ, Jakubowski JA, Zhou C, Fox KAA, Armstrong PW, White HD, Prabhakaran D, Ohman EM, Huber K; TRILOGY ACS Investigators. Temporal Biomarker Profiling Reveals Longitudinal Changes in Risk of Death or Myocardial Infarction in Non-ST-Segment Elevation Acute Coronary Syndrome. Clin Chem. 2017 Jul;63(7):1214-1226. doi: 10.1373/clinchem.2016.265272. Epub 2017 May 17.
PubMed 28515099Goldstein SA, Newby LK, Cyr DD, Neely M, Luscher TF, Brown EB, White HD, Ohman EM, Roe MT, Hamm CW. Relationship Between Peak Troponin Values and Long-Term Ischemic Events Among Medically Managed Patients With Acute Coronary Syndromes. J Am Heart Assoc. 2017 Apr 11;6(4):e005334. doi: 10.1161/JAHA.116.005334.
PubMed 28400368Alfredsson J, Neely B, Neely ML, Bhatt DL, Goodman SG, Tricoci P, Mahaffey KW, Cornel JH, White HD, Fox KA, Prabhakaran D, Winters KJ, Armstrong PW, Ohman EM, Roe MT; TRILOGY ACS Investigators. Predicting the risk of bleeding during dual antiplatelet therapy after acute coronary syndromes. Heart. 2017 Aug;103(15):1168-1176. doi: 10.1136/heartjnl-2016-310090. Epub 2017 Apr 5.
PubMed 28381584Cornel JH, Ohman EM, Neely B, Jakubowski JA, Bhatt DL, White HD, Ardissino D, Fox KA, Prabhakaran D, Armstrong PW, Erlinge D, Tantry US, Gurbel PA, Roe MT. Relationship of Platelet Reactivity With Bleeding Outcomes During Long-Term Treatment With Dual Antiplatelet Therapy for Medically Managed Patients With Non-ST-Segment Elevation Acute Coronary Syndromes. J Am Heart Assoc. 2016 Nov 4;5(11):e003977. doi: 10.1161/JAHA.116.003977.
PubMed 27815268Chin CT, Boden WE, Roe MT, Neely B, Neely ML, Leiva-Pons JL, Corbalan R, Gottlieb S, Dalby AJ, Armstrong PW, Prabhakaran D, Fox KA, White HD, Ohman EM, Winters KJ, Schiele F. Effect of prior clopidogrel use on outcomes in medically managed acute coronary syndrome patients. Heart. 2016 Aug 1;102(15):1221-9. doi: 10.1136/heartjnl-2015-308840. Epub 2016 Mar 30.
PubMed 27030601Lopes RD, Leonardi S, Neely B, Neely ML, Ohman EM, Ardissino D, Hamm CW, Goodman SG, Bhatt DL, White HD, Prabhakaran D, Martinez F, Nicolau JC, Winters KJ, Fox KA, Armstrong PW, Roe MT. Spontaneous MI After Non-ST-Segment Elevation Acute Coronary Syndrome Managed Without Revascularization: The TRILOGY ACS Trial. J Am Coll Cardiol. 2016 Mar 22;67(11):1289-97. doi: 10.1016/j.jacc.2016.01.034.
PubMed 26988949Doll JA, Neely ML, Roe MT, Armstrong PW, White HD, Prabhakaran D, Winters KJ, Duvvuru S, Sundseth SS, Jakubowski JA, Gurbel PA, Bhatt DL, Ohman EM, Fox KAA; TRILOGY ACS Investigators. Impact of CYP2C19 Metabolizer Status on Patients With ACS Treated With Prasugrel Versus Clopidogrel. J Am Coll Cardiol. 2016 Mar 1;67(8):936-947. doi: 10.1016/j.jacc.2015.12.036.
PubMed 26916483Chin CT, Neely B, Magnus Ohman E, Armstrong PW, Corbalan R, White HD, Prabhakaran D, Winters KJ, Fox KA, Roe MT; TRILOGY ACS Investigators. Time-Varying Effects of Prasugrel Versus Clopidogrel on the Long-Term Risks of Stroke After Acute Coronary Syndromes: Results From the TRILOGY ACS Trial. Stroke. 2016 Apr;47(4):1135-9. doi: 10.1161/STROKEAHA.115.012454. Epub 2016 Feb 16.
PubMed 26883498Roe MT, Cyr DD, Eckart D, Schulte PJ, Morse MA, Blackwell KL, Ready NE, Zafar SY, Beaven AW, Strickler JH, Onken JE, Winters KJ, Houterloot L, Zamoryakhin D, Wiviott SD, White HD, Prabhakaran D, Fox KA, Armstrong PW, Ohman EM; TRILOGY ACS Investigators. Ascertainment, classification, and impact of neoplasm detection during prolonged treatment with dual antiplatelet therapy with prasugrel vs. clopidogrel following acute coronary syndrome. Eur Heart J. 2016 Jan 21;37(4):412-22. doi: 10.1093/eurheartj/ehv611. Epub 2015 Dec 5.
PubMed 26637834Clemmensen P, Roe MT, Hochman JS, Cyr DD, Neely ML, McGuire DK, Cornel JH, Huber K, Zamoryakhin D, White HD, Armstrong PW, Fox KA, Prabhakaran D, Ohman EM; TRILOGY ACS Investigators. Long-term outcomes for women versus men with unstable angina/non-ST-segment elevation myocardial infarction managed medically without revascularization: insights from the TaRgeted platelet Inhibition to cLarify the Optimal strateGy to medicallY manage Acute Coronary Syndromes trial. Am Heart J. 2015 Oct;170(4):695-705.e5. doi: 10.1016/j.ahj.2015.06.011. Epub 2015 Jun 20.
PubMed 26386793