TRILOGY
Eligibility
Persons may be eligible to participate in this trial if they meet the following criteria.
- Have has a US/NSTEMI index event within 10 days prior to randomization
- Had a medical management strategy decision made with reasonable certainty that neither PCI or 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
Persons may be excluded from this trial if they meet the following 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 CAD on coronary angiography if performed for Index Event (absence of greter thn or equal to 30% stenosis in at least one native vessel)
- Previous or planned PCI or CABG for the index event
- PCI/CABG within previous 30 days
- STEMI as the index event
- Cardiogenic shock, Refractory ventricular arrhythmias, NYHA class IV CHF within previous 24 hours
- History of ischemic or hemorrhagic stroke, TIA, Intracranial neoplasm, arteiovenous malformation, or aneurysm
- History of spontaneous GI or non-GI bleeding requiring hospitalization for treatment, unless definitive Rx has occurred and there is low likelihood of recurrence
- Hemodialysis or peritoneal dialysis
Complete Title
A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome Subjects (TRILOGY ACS)
Purpose
This study will evaluate the relative efficacy and safety of prasugrel and clopidogrel in a medically managed US/NSTEMI ACS population (that is, patients who are not managed with acute coronary revascularization).
Summary
This is an interventional treatment, randomized, double blind, active control, parallel assignment, safety/efficacy study comparing prasugrel and clopidogrel in acute coronary syndrome subjects with unstable angina/non-ST-elevation myocardial infarction who are medically managed.
Sponsor(s)