A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome Subjects
NCT ID: NCT00699998
Last Updated: 2013-05-07
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
9326 participants
Study Classification
INTERVENTIONAL
Study Start Date
2008-06-30
Study Completion Date
2012-04-30
Brief Summary
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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).
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Detailed Description
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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
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Acute Coronary Syndrome
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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Prasugrel
Prasugrel and Low-dose Commercially-available Aspirin
Group Type
EXPERIMENTAL
Prasugrel
Intervention Type
DRUG
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 Aspirin
Intervention Type
DRUG
Low-dose aspirin, oral, as prescribed by physician through end of study
Clopidogrel
Clopidogrel and Low-Dose Commercially-available Aspirin
Group Type
ACTIVE_COMPARATOR
Clopidogrel
Intervention Type
DRUG
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
Commercially-available Aspirin
Intervention Type
DRUG
Low-dose aspirin, oral, as prescribed by physician through end of study
Interventions
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Clopidogrel
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
Intervention Type
DRUG
Prasugrel
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
Intervention Type
DRUG
Commercially-available Aspirin
Low-dose aspirin, oral, as prescribed by physician through end of study
Intervention Type
DRUG
Other Intervention Names
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LY640315
Effient
Efient
CS-747
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion Criteria
* 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
* 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
* 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
* 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
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Daiichi Sankyo Co., Ltd.
INDUSTRY
Sponsor Role
collaborator
Duke Clinical Research Institute
OTHER
Sponsor Role
collaborator
Eli Lilly and Company
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Flint, Michigan, United States
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Minneapolis, Minnesota, United States
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Picayune, Mississippi, United States
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Columbia, Missouri, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Kalispell, Montana, United States
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Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
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Nashua, New Hampshire, United States
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Bridgewater, New Jersey, United States
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Cherry Hill, New Jersey, United States
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Flemington, New Jersey, United States
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Ridgewood, New Jersey, United States
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Brooklyn, New York, United States
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Buffalo, New York, United States
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Flushing, New York, United States
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New Hartford, New York, United States
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New York, New York, United States
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Syracuse, New York, United States
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The Bronx, New York, United States
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Chapel Hill, North Carolina, United States
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Charlotte, North Carolina, United States
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Elizabeth City, North Carolina, United States
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Gastonia, North Carolina, United States
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Hickory, North Carolina, United States
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Lenoir, North Carolina, United States
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Matthews, North Carolina, United States
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Pinehurst, North Carolina, United States
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Salisbury, North Carolina, United States
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Sanford, North Carolina, United States
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Statesville, North Carolina, United States
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Wilmington, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Mansfield, Ohio, United States
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Toledo, Ohio, United States
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Zanesville, Ohio, United States
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Muskogee, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Hillsboro, Oregon, United States
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Portland, Oregon, United States
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Abington, Pennsylvania, United States
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Bethlehem, Pennsylvania, United States
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Chambersburg, Pennsylvania, United States
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Clarks Summit, Pennsylvania, United States
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Doylestown, Pennsylvania, United States
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Erie, Pennsylvania, United States
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Greensburg, Pennsylvania, United States
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Harrisburg, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Pottstown, Pennsylvania, United States
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Sayre, Pennsylvania, United States
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Sellersville, Pennsylvania, United States
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West Chester, Pennsylvania, United States
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Wormleysburg, Pennsylvania, United States
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Charleston, South Carolina, United States
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Rock Hill, South Carolina, United States
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Rapid City, South Dakota, United States
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Sioux Falls, South Dakota, United States
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Chattanooga, Tennessee, United States
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Germantown, Tennessee, United States
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Hendersonville, Tennessee, United States
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Jackson, Tennessee, United States
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Johnson City, Tennessee, United States
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Knoxville, Tennessee, United States
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Lexington, Tennessee, United States
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Memphis, Tennessee, United States
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Oak Ridge, Tennessee, United States
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Amarillo, Texas, United States
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Austin, Texas, United States
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Corpus Christi, Texas, United States
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Edinburg, Texas, United States
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Fort Sam Houston, Texas, United States
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Houston, Texas, United States
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Lackland Air Force Base, Texas, United States
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San Antonio, Texas, United States
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Victoria, Texas, United States
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American Fork, Utah, United States
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Salt Lake City, Utah, United States
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Charlottesville, Virginia, United States
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Danville, Virginia, United States
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Hopewell, Virginia, United States
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Lake Ridge, Virginia, United States
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Manassas, Virginia, United States
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Newport News, Virginia, United States
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Richmond, Virginia, United States
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Roanoke, Virginia, United States
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Seattle, Washington, United States
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Spokane, Washington, United States
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Tacoma, Washington, United States
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Burlington, Wisconsin, United States
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Milwaukee, Wisconsin, United States
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Bahía Blanca, , Argentina
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Buenos Aires, , Argentina
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Caba, , Argentina
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Concordia, , Argentina
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Corrientes, , Argentina
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Córdoba, , Argentina
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Formosa, , Argentina
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Godoy Cruz, , Argentina
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La Plata, , Argentina
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Mar del Plata, , Argentina
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Morón, , Argentina
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Rosario, , Argentina
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Salta, , Argentina
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San Luis, , Argentina
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San Miguel de Tucumán, , Argentina
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Santa Fe, , Argentina
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Villa Cabrera, , Argentina
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Villa María, , Argentina
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Coffs Harbour, New South Wales, Australia
Site Status
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Lismore, New South Wales, Australia
Site Status
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Newcastle, New South Wales, Australia
Site Status
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Wollongong, New South Wales, Australia
Site Status
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Herston, Queensland, Australia
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Nambour, Queensland, Australia
Site Status
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Redcliffe, Queensland, Australia
Site Status
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Southport, Queensland, Australia
Site Status
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Bedford Park, South Australia, Australia
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Elizabeth Vale, South Australia, Australia
Site Status
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Hobart, Tasmania, Australia
Site Status
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Feldkirch, , Austria
Site Status
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Vienna, , Austria
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Brussels, , Belgium
Site Status
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Huy, , Belgium
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Liège, , Belgium
Site Status
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Mol, , Belgium
Site Status
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Overpelt, , Belgium
Site Status
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Aracaju, , Brazil
Site Status
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Belo Horizonte, , Brazil
Site Status
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Blumenau, , Brazil
Site Status
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Brasília, , Brazil
Site Status
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Campina Grande do Sul, , Brazil
Site Status
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Campinas, , Brazil
Site Status
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Campo Grande, , Brazil
Site Status
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Caxias do Sul, , Brazil
Site Status
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Curitiba, , Brazil
Site Status
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Dois Lajeados, , Brazil
Site Status
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Goiânia, , Brazil
Site Status
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Maceió, , Brazil
Site Status
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Maringá, , Brazil
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Passo Fundo, , Brazil
Site Status
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Piracicaba, , Brazil
Site Status
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Porto Alegre, , Brazil
Site Status
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Recife, , Brazil
Site Status
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Ribeirão Preto, , Brazil
Site Status
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Rio de Janeiro, , Brazil
Site Status
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Salvador, , Brazil
Site Status
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Santo André, , Brazil
Site Status
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Sao Jose Rio Preto, , Brazil
Site Status
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São Caetano do Sul, , Brazil
Site Status
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São José, , Brazil
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São Paulo, , Brazil
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Uberlândia, , Brazil
Site Status
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Votuporanga, , Brazil
Site Status
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Dimitrovgrad, , Bulgaria
Site Status
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Haskovo, , Bulgaria
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Kazanlak, , Bulgaria
Site Status
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Kyustendil, , Bulgaria
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Pazardzhik, , Bulgaria
Site Status
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Pleven, , Bulgaria
Site Status
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Plovdiv, , Bulgaria
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Rousse, , Bulgaria
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Sofia, , Bulgaria
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Varna, , Bulgaria
Site Status
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Edmonton, Alberta, Canada
Site Status
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Campbell River, British Columbia, Canada
Site Status
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St. John's, Newfoundland and Labrador, Canada
Site Status
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Halifax, Nova Scotia, Canada
Site Status
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Ajax, Ontario, Canada
Site Status
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Burlington, Ontario, Canada
Site Status
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Cambridge, Ontario, Canada
Site Status
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Greater Sudbury, Ontario, Canada
Site Status
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London, Ontario, Canada
Site Status
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Oshawa, Ontario, Canada
Site Status
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Sarnia, Ontario, Canada
Site Status
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Scarborough Village, Ontario, Canada
Site Status
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Montreal, Quebec, Canada
Site Status
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Sainte-Foy, Quebec, Canada
Site Status
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La Serena, , Chile
Site Status
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Osorno, , Chile
Site Status
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Puente Alto, , Chile
Site Status
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Rancagua, , Chile
Site Status
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Santiago, , Chile
Site Status
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Temuco, , Chile
Site Status
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Viña del Mar, , Chile
Site Status
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Beijing, , China
Site Status
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Beijing, , China
Site Status
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Changsha, , China
Site Status
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Fuzhou, , China
Site Status
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Guangzhou, , China
Site Status
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Hangzhou, , China
Site Status
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Harbin, , China
Site Status
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Jiangsu, , China
Site Status
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Nanchang, , China
Site Status
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Nanjing, , China
Site Status
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Shanghai, , China
Site Status
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Shaoguan, , China
Site Status
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Shengyang, , China
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Shenyang, , China
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Shijiazhuang, , China
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Suzhou, , China
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Wenzhou, , China
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Wuhan, , China
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Wuhan, , China
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Xi'an, , China
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Xuzhou, , China
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Zhengzhou, , China
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Armenia-Quindio, , Colombia
Site Status
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Barranquilla, , Colombia
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Bogotá, , Colombia
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Cali, , Colombia
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Floridablanca, , Colombia
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Medellín, , Colombia
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San José, , Costa Rica
Site Status
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Dubrovnik, , Croatia
Site Status
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Karlovac, , Croatia
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Koprivnica, , Croatia
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Krapinske Toplice, , Croatia
Site Status
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Rijeka, , Croatia
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Slavonski Brod, , Croatia
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Split, , Croatia
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Varaždin, , Croatia
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Zadar, , Croatia
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Zagreb, , Croatia
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Děčín, , Czechia
Site Status
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Frýdek-Místek, , Czechia
Site Status
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Hradec Králové, , Czechia
Site Status
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Karlovy Vary, , Czechia
Site Status
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Kroměříž, , Czechia
Site Status
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Liberec, , Czechia
Site Status
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Nový Jičín, , Czechia
Site Status
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Pardubice, , Czechia
Site Status
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Prague, , Czechia
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Zlín, , Czechia
Site Status
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Copenhagen, , Denmark
Site Status
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Copenhagen, , Denmark
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Hellerup, , Denmark
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Alexandria, , Egypt
Site Status
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Beni Sweif, , Egypt
Site Status
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Cairo, , Egypt
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Ismailia, , Egypt
Site Status
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Menoufiya, , Egypt
Site Status
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Jyväskylä, , Finland
Site Status
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Angers, , France
Site Status
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Arras, , France
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Besançon, , France
Site Status
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Cambrai, , France
Site Status
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Chartres, , France
Site Status
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Dijon, , France
Site Status
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Douai, , France
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La Roche-sur-Yon, , France
Site Status
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Lagny-sur-Marne, , France
Site Status
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Nantes, , France
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Nice, , France
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Paris, , France
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Pessac, , France
Site Status
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Poitiers, , France
Site Status
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Strasbourg, , France
Site Status
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Toulouse, , France
Site Status
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Valenciennes, , France
Site Status
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Vandœuvre-lès-Nancy, , France
Site Status
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Bad Nauheim, , Germany
Site Status
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Cologne, , Germany
Site Status
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Darmstadt, , Germany
Site Status
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Dortmund, , Germany
Site Status
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Frankfurt, , Germany
Site Status
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Halle, , Germany
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Idar-Oberstein, , Germany
Site Status
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Leipzig, , Germany
Site Status
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Mainz, , Germany
Site Status
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Mannheim, , Germany
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Stuttgart, , Germany
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Tübingen, , Germany
Site Status
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Athens, , Greece
Site Status
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Haidari/Athens, , Greece
Site Status
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Kallithea, , Greece
Site Status
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Magoula, , Greece
Site Status
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Pátrai, , Greece
Site Status
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Rhodes, , Greece
Site Status
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Trikala, , Greece
Site Status
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Baja, , Hungary
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Békéscsaba, , Hungary
Site Status
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Budapest, , Hungary
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Kalocsa, , Hungary
Site Status
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Kecskemét, , Hungary
Site Status
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Komárom, , Hungary
Site Status
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Miskolc, , Hungary
Site Status
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Sátoraljaújhely, , Hungary
Site Status
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Sopron, , Hungary
Site Status
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Szekszárd, , Hungary
Site Status
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Zalaegerszeg, , Hungary
Site Status
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Ahmedabad, , India
Site Status
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Anand, , India
Site Status
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Aurangabad, , India
Site Status
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Bangalore, , India
Site Status
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Bārāmati, , India
Site Status
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Bikaner, , India
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Calicut, , India
Site Status
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Chidambaram, , India
Site Status
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Coimbatore, , India
Site Status
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Ernākulam, , India
Site Status
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Guntur, , India
Site Status
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Gurgaon, , India
Site Status
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Hyderabaad, , India
Site Status
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Indore, , India
Site Status
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Jaipur, , India
Site Status
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Jalandhar, , India
Site Status
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Kochi, , India
Site Status
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Kolkata, , India
Site Status
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Kottayam, , India
Site Status
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Lucknow, , India
Site Status
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Madurai, , India
Site Status
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Mumbai, , India
Site Status
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Mysore, , India
Site Status
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Nagpur, , India
Site Status
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Nashik, , India
Site Status
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New Delhi, , India
Site Status
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Patiāla, , India
Site Status
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Pune, , India
Site Status
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Sāket, , India
Site Status
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Secunderabad, , India
Site Status
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Shivamogga, , India
Site Status
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Solapur, , India
Site Status
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Surat, , India
Site Status
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Thrissur, , India
Site Status
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Tirupati, , India
Site Status
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Trivandrum, , India
Site Status
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Vadodara, , India
Site Status
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Vijayawada, , India
Site Status
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Visakhapatnam, , India
Site Status
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Dublin, , Ireland
Site Status
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Galway, , Ireland
Site Status
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Afula, , Israel
Site Status
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Ashkelon, , Israel
Site Status
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Beersheba, , Israel
Site Status
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Eilat, , Israel
Site Status
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Haifa, , Israel
Site Status
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Jerusalem, , Israel
Site Status
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Kfar Saba, , Israel
Site Status
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Nahariya, , Israel
Site Status
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Nazareth, , Israel
Site Status
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Rehovot, , Israel
Site Status
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Tel Aviv, , Israel
Site Status
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Tel Litwinsky, , Israel
Site Status
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Tiberias, , Israel
Site Status
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Tzfat, , Israel
Site Status
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Albano Laziale, , Italy
Site Status
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Ascoli Piceno, , Italy
Site Status
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Bari, , Italy
Site Status
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Bergamo, , Italy
Site Status
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Brescia, , Italy
Site Status
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Caserta, , Italy
Site Status
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Forlì, , Italy
Site Status
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Lecco, , Italy
Site Status
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Legnago, , Italy
Site Status
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Legnano, , Italy
Site Status
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Milan, , Italy
Site Status
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Novara, , Italy
Site Status
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Parma, , Italy
Site Status
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Perugia, , Italy
Site Status
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Pescara, , Italy
Site Status
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Reggio Emilia, , Italy
Site Status
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Rimini, , Italy
Site Status
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Rome, , Italy
Site Status
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San Daniele del Friuli, , Italy
Site Status
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Santa Maria Capua Vetere, , Italy
Site Status
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Saronno, , Italy
Site Status
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Sorrento, , Italy
Site Status
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Terni, , Italy
Site Status
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Trieste, , Italy
Site Status
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Kaunas, , Lithuania
Site Status
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Klaipėda, , Lithuania
Site Status
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Šiauliai, , Lithuania
Site Status
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Vilnius, , Lithuania
Site Status
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Cheras, Kuala Lumpur, , Malaysia
Site Status
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Johor Bahru, , Malaysia
Site Status
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Kelantan, , Malaysia
Site Status
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Kuala Lumpur, , Malaysia
Site Status
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Kuala Selangor, , Malaysia
Site Status
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Kuantan Pahang, , Malaysia
Site Status
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Perak, , Malaysia
Site Status
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Sarawak, , Malaysia
Site Status
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Taiping Perak, , Malaysia
Site Status
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Gozo, , Malta
Site Status
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Msida, , Malta
Site Status
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Aguascalientes, , Mexico
Site Status
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Culiacán, , Mexico
Site Status
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Durango, , Mexico
Site Status
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Jalisco, , Mexico
Site Status
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León, , Mexico
Site Status
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Monterrey, , Mexico
Site Status
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Puebla City, , Mexico
Site Status
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Querétaro, , Mexico
Site Status
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San Luis Potosí City, , Mexico
Site Status
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Tijuana, , Mexico
Site Status
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Alkmaar, , Netherlands
Site Status
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Almelo, , Netherlands
Site Status
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Amsterdam, , Netherlands
Site Status
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Apeldoorn, , Netherlands
Site Status
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Beverwijk, , Netherlands
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Blaricum, , Netherlands
Site Status
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Delft, , Netherlands
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Ede, , Netherlands
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Eindhoven, , Netherlands
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Gouda, , Netherlands
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Hoorn, , Netherlands
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Leeuwarden, , Netherlands
Site Status
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Leiden, , Netherlands
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Leiderdorp, , Netherlands
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Meppel, , Netherlands
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Oss, , Netherlands
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Roosendaal, , Netherlands
Site Status
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Venlo, , Netherlands
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Auckland, , New Zealand
Site Status
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Christchurch, , New Zealand
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Nelson, , New Zealand
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Wellington, , New Zealand
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Coclé, , Panama
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David, , Panama
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Panama City, , Panama
Site Status
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Arequipa, , Peru
Site Status
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Callao, , Peru
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Cuzco, , Peru
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Lima, , Peru
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Cagayan de de Oro, , Philippines
Site Status
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Cavite City, , Philippines
Site Status
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Davao City, , Philippines
Site Status
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Iloilo City, , Philippines
Site Status
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Manila, , Philippines
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Marikina City, , Philippines
Site Status
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Metro Manila, , Philippines
Site Status
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Pasig, , Philippines
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Quezon City, , Philippines
Site Status
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Quezon City, , Philippines
Site Status
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Bydgoszcz, , Poland
Site Status
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Elblag, , Poland
Site Status
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Gdansk, , Poland
Site Status
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Katowice, , Poland
Site Status
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Koszalin, , Poland
Site Status
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Krakow, , Poland
Site Status
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Kutno, , Poland
Site Status
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Lodz, , Poland
Site Status
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Lubin, , Poland
Site Status
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Lublin, , Poland
Site Status
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Myślenice, , Poland
Site Status
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Nowy Sącz, , Poland
Site Status
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Oława, , Poland
Site Status
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Piotrkow Trybunalski, , Poland
Site Status
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Puławy, , Poland
Site Status
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Ruda Śląska, , Poland
Site Status
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Skierniewice, , Poland
Site Status
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Szczecin, , Poland
Site Status
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Warsaw, , Poland
Site Status
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Wałbrzych, , Poland
Site Status
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Wejherowo, , Poland
Site Status
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Wroclaw, , Poland
Site Status
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Aveiro, , Portugal
Site Status
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Carnaxide, , Portugal
Site Status
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Coimbra, , Portugal
Site Status
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Leiria, , Portugal
Site Status
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Ponta Delgada, , Portugal
Site Status
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Santarém, , Portugal
Site Status
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Setúbal, , Portugal
Site Status
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Vila Franca de Xira, , Portugal
Site Status
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Caguas, , Puerto Rico
Site Status
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Mayagüez, , Puerto Rico
Site Status
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San Juan, , Puerto Rico
Site Status
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Bacau, , Romania
Site Status
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Baia Mare, , Romania
Site Status
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Brasov, , Romania
Site Status
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Brăila, , Romania
Site Status
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Bucharest, , Romania
Site Status
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Buzău, , Romania
Site Status
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Cluj-Napoca, , Romania
Site Status
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Focşani, , Romania
Site Status
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Piteşti, , Romania
Site Status
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Suceava, , Romania
Site Status
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Târgovişte, , Romania
Site Status
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Arkhangelsk, , Russia
Site Status
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Gatchina, , Russia
Site Status
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Kazan', , Russia
Site Status
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Kemerovo, , Russia
Site Status
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Krasnoyarsk, , Russia
Site Status
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Moscow, , Russia
Site Status
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Nizhny Novgorod, , Russia
Site Status
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Novokuznetsk, , Russia
Site Status
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Novosibirsk, , Russia
Site Status
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Omsk, , Russia
Site Status
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Rostov-on-Don, , Russia
Site Status
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Saint Petersburg, , Russia
Site Status
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Saratov, , Russia
Site Status
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Tomsk, , Russia
Site Status
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Tyumen, , Russia
Site Status
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Belgrade, , Serbia
Site Status
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Kragujevac, , Serbia
Site Status
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Niš, , Serbia
Site Status
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Niška Banja, , Serbia
Site Status
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Zemun, , Serbia
Site Status
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Singapore, , Singapore
Site Status
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Bratislava, , Slovakia
Site Status
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Levice, , Slovakia
Site Status
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Martin, , Slovakia
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Nitra, , Slovakia
Site Status
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Nové Zámky, , Slovakia
Site Status
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Prešov, , Slovakia
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Ružomberok, , Slovakia
Site Status
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Žilina, , Slovakia
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Alberton, , South Africa
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Bloemfontein, , South Africa
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Cape Town, , South Africa
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Durban, , South Africa
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George, , South Africa
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Johannesburg, , South Africa
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Parktown West, , South Africa
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Somerset West, , South Africa
Site Status
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Worcester, , South Africa
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Busan, , South Korea
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Daegu, , South Korea
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Daejeon, , South Korea
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Gangwon-Do, , South Korea
Site Status
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Gwangju, , South Korea
Site Status
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Incheon, , South Korea
Site Status
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Jeonju, , South Korea
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Jinju, , South Korea
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Seoul, , South Korea
Site Status
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Ulsan, , South Korea
Site Status
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Barcelona, , Spain
Site Status
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Girona, , Spain
Site Status
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Málaga, , Spain
Site Status
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Palma de Mallorca, , Spain
Site Status
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Reus, , Spain
Site Status
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San Boi de Llobregat, , Spain
Site Status
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Seville, , Spain
Site Status
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Valencia, , Spain
Site Status
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Bollnäs, , Sweden
Site Status
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Karlstad, , Sweden
Site Status
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Lund, , Sweden
Site Status
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Bellinzona, , Switzerland
Site Status
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Winterthur, , Switzerland
Site Status
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Kaohsiung City, , Taiwan
Site Status
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Taipei, , Taiwan
Site Status
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Bangkok, , Thailand
Site Status
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Chiang Mai, , Thailand
Site Status
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Khon Kaen, , Thailand
Site Status
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Nakhon Ratchasima, , Thailand
Site Status
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Pathum Thani, , Thailand
Site Status
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Udon Thani, , Thailand
Site Status
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La Marsa, , Tunisia
Site Status
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Menzel Bourguiba, , Tunisia
Site Status
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Monastir, , Tunisia
Site Status
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Sfax, , Tunisia
Site Status
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Sousse, , Tunisia
Site Status
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Tunis, , Tunisia
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Tunis Monfleury, , Tunisia
Site Status
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Adana, , Turkey (Türkiye)
Site Status
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Ankara, , Turkey (Türkiye)
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Bolu, , Turkey (Türkiye)
Site Status
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Bursa, , Turkey (Türkiye)
Site Status
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Edirne, , Turkey (Türkiye)
Site Status
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Erzurum, , Turkey (Türkiye)
Site Status
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Isparta, , Turkey (Türkiye)
Site Status
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Istanbul, , Turkey (Türkiye)
Site Status
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Kocaeli, , Turkey (Türkiye)
Site Status
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Konya, , Turkey (Türkiye)
Site Status
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Kırıkkale, , Turkey (Türkiye)
Site Status
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Samsun, , Turkey (Türkiye)
Site Status
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Trabzon, , Turkey (Türkiye)
Site Status
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Cherkasy, , Ukraine
Site Status
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Dnipropetrovsk, , Ukraine
Site Status
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Donetsk, , Ukraine
Site Status
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Ivano-Frankivsk, , Ukraine
Site Status
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Kharkiv, , Ukraine
Site Status
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Kiev, , Ukraine
Site Status
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Kryvyy Rig, , Ukraine
Site Status
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Kyiv, , Ukraine
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Luhansk, , Ukraine
Site Status
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Lutsk, , Ukraine
Site Status
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Lviv, , Ukraine
Site Status
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Mykolayiv, , Ukraine
Site Status
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Odesa, , Ukraine
Site Status
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Poltava, , Ukraine
Site Status
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Simferopol, , Ukraine
Site Status
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Vinnytsia, , Ukraine
Site Status
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Zaporizhzhya, , Ukraine
Site Status
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Stockton-on-Tees, Cleveland, United Kingdom
Site Status
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Torquay, Cnwll, United Kingdom
Site Status
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Durham, County Durham, United Kingdom
Site Status
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Chesterfield, Derbyshire, United Kingdom
Site Status
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Plymouth, Devon, United Kingdom
Site Status
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Brighton, East Sussex, United Kingdom
Site Status
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Cottingham, East Yorkshire, United Kingdom
Site Status
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Colchester, Essex, United Kingdom
Site Status
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Romford, Essex, United Kingdom
Site Status
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London, Greater London, United Kingdom
Site Status
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Southall, Greater London, United Kingdom
Site Status
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Newport, Gwent, United Kingdom
Site Status
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Portsmouth, Hampshire, United Kingdom
Site Status
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Orpington, Kent, United Kingdom
Site Status
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Lincoln, Lincolnshire, United Kingdom
Site Status
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Metropolitan Borough of Wirral, Merseyside, United Kingdom
Site Status
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York, North Yorkshire, United Kingdom
Site Status
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Nottingham, Nottinghamshire, United Kingdom
Site Status
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Yeovil, Somerset, United Kingdom
Site Status
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Sunderland, Sunderland, United Kingdom
Site Status
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Dundee, Tays, United Kingdom
Site Status
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Nuneaton, Warwickshire, United Kingdom
Site Status
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Warwick, Warwickshire, United Kingdom
Site Status
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Livingston, West Lothian, United Kingdom
Site Status
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Birmingham, West Midlands, United Kingdom
Site Status
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Dudley, West Midlands, United Kingdom
Site Status
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West Bromwich, West Midlands, United Kingdom
Site Status
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Wolverhampton, West Midlands, United Kingdom
Site Status
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Bradford, West Yorkshire, United Kingdom
Site Status
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Northampton, , United Kingdom
Site Status
Countries
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United States
Argentina
Australia
Austria
Belgium
Brazil
Bulgaria
Canada
Chile
China
Colombia
Costa Rica
Croatia
Czechia
Denmark
Egypt
Finland
France
Germany
Greece
Hungary
India
Ireland
Israel
Italy
Lithuania
Malaysia
Malta
Mexico
Netherlands
New Zealand
Panama
Peru
Philippines
Poland
Portugal
Puerto Rico
Romania
Russia
Serbia
Singapore
Slovakia
South Africa
South Korea
Spain
Sweden
Switzerland
Taiwan
Thailand
Tunisia
Turkey (Türkiye)
Ukraine
United Kingdom
References
Explore related publications, articles, or registry entries linked to this study.
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.
Reference Type
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Marquis-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.
Reference Type
DERIVED
Kaul 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.
Reference Type
DERIVED
Fanaroff 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.
Reference Type
DERIVED
Inohara 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.
Reference Type
DERIVED
Chan 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.
Reference Type
DERIVED
Goldstein 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.
Reference Type
DERIVED
Alfredsson 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.
Reference Type
DERIVED
Cornel 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.
Reference Type
DERIVED
Chin 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.
Reference Type
DERIVED
Lopes 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.
Reference Type
DERIVED
Doll 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.
Reference Type
DERIVED
Chin 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.
Reference Type
DERIVED
Roe 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.
Reference Type
DERIVED
Clemmensen 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.
Reference Type
DERIVED
Mahaffey KW, Hager R, Wojdyla D, White HD, Armstrong PW, Alexander JH, Tricoci P, Lopes RD, Ohman EM, Roe MT, Harrington RA, Wallentin L. Meta-analysis of intracranial hemorrhage in acute coronary syndromes: incidence, predictors, and clinical outcomes. J Am Heart Assoc. 2015 Jun 18;4(6):e001512. doi: 10.1161/JAHA.114.001512.
Reference Type
DERIVED
Roy A, Roe MT, Neely ML, Cyr DD, Zamoryakhin D, Fox KA, White HD, Armstrong PW, Ohman EM, Prabhakaran D. Impact of Human Development Index on the profile and outcomes of patients with acute coronary syndrome. Heart. 2015 Feb;101(4):279-86. doi: 10.1136/heartjnl-2014-306389. Epub 2014 Dec 23.
Reference Type
DERIVED
Bakal JA, Roe MT, Ohman EM, Goodman SG, Fox KA, Zheng Y, Westerhout CM, Hochman JS, Lokhnygina Y, Brown EB, Armstrong PW. Applying novel methods to assess clinical outcomes: insights from the TRILOGY ACS trial. Eur Heart J. 2015 Feb 7;36(6):385-92a. doi: 10.1093/eurheartj/ehu262. Epub 2014 Jul 10.
Reference Type
DERIVED
Cornel JH, Ohman EM, Neely B, Clemmensen P, Sritara P, Zamoryakhin D, Armstrong PW, Prabhakaran D, White HD, Fox KA, Gurbel PA, Roe MT; TRILOGY ACS Investigators. Impact of smoking status on platelet function and clinical outcomes with prasugrel vs. clopidogrel in patients with acute coronary syndromes managed without revascularization: Insights from the TRILOGY ACS trial. Am Heart J. 2014 Jul;168(1):76-87.e1. doi: 10.1016/j.ahj.2014.04.011. Epub 2014 Apr 24.
Reference Type
DERIVED
Wiviott SD, White HD, Ohman EM, Fox KA, Armstrong PW, Prabhakaran D, Hafley G, Lokhnygina Y, Boden WE, Hamm C, Clemmensen P, Nicolau JC, Menozzi A, Ruzyllo W, Widimsky P, Oto A, Leiva-Pons J, Pavlides G, Winters KJ, Roe MT, Bhatt DL. Prasugrel versus clopidogrel for patients with unstable angina or non-ST-segment elevation myocardial infarction with or without angiography: a secondary, prespecified analysis of the TRILOGY ACS trial. Lancet. 2013 Aug 17;382(9892):605-13. doi: 10.1016/S0140-6736(13)61451-8.
Reference Type
DERIVED
Gurbel PA, Erlinge D, Ohman EM, Neely B, Neely M, Goodman SG, Huber K, Chan MY, Cornel JH, Brown E, Zhou C, Jakubowski JA, White HD, Fox KA, Prabhakaran D, Armstrong PW, Tantry US, Roe MT; TRILOGY ACS Platelet Function Substudy Investigators. Platelet function during extended prasugrel and clopidogrel therapy for patients with ACS treated without revascularization: the TRILOGY ACS platelet function substudy. JAMA. 2012 Nov 7;308(17):1785-94. doi: 10.1001/jama.2012.17312.
Reference Type
DERIVED
Roe MT, Armstrong PW, Fox KA, White HD, Prabhakaran D, Goodman SG, Cornel JH, Bhatt DL, Clemmensen P, Martinez F, Ardissino D, Nicolau JC, Boden WE, Gurbel PA, Ruzyllo W, Dalby AJ, McGuire DK, Leiva-Pons JL, Parkhomenko A, Gottlieb S, Topacio GO, Hamm C, Pavlides G, Goudev AR, Oto A, Tseng CD, Merkely B, Gasparovic V, Corbalan R, Cinteza M, McLendon RC, Winters KJ, Brown EB, Lokhnygina Y, Aylward PE, Huber K, Hochman JS, Ohman EM; TRILOGY ACS Investigators. Prasugrel versus clopidogrel for acute coronary syndromes without revascularization. N Engl J Med. 2012 Oct 4;367(14):1297-309. doi: 10.1056/NEJMoa1205512. Epub 2012 Aug 25.
Reference Type
DERIVED
Jeong YH, Tantry US, Gurbel PA. Importance of potent P2Y(12) receptor blockade in acute myocardial infarction: focus on prasugrel. Expert Opin Pharmacother. 2012 Aug;13(12):1771-96. doi: 10.1517/14656566.2012.704909. Epub 2012 Jul 12.
Reference Type
DERIVED
Chin CT, Roe MT, Fox KA, Prabhakaran D, Marshall DA, Petitjean H, Lokhnygina Y, Brown E, Armstrong PW, White HD, Ohman EM; TRILOGY ACS Steering Committee. Study design and rationale of a comparison of prasugrel and clopidogrel in medically managed patients with unstable angina/non-ST-segment elevation myocardial infarction: the TaRgeted platelet Inhibition to cLarify the Optimal strateGy to medicallY manage Acute Coronary Syndromes (TRILOGY ACS) trial. Am Heart J. 2010 Jul;160(1):16-22.e1. doi: 10.1016/j.ahj.2010.04.022.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
H7T-MC-TABY(b)
Identifier Type: OTHER
Identifier Source: secondary_id
11058
Identifier Type: -
Identifier Source: org_study_id
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