Yükleniyor... / Loading...
This study compared the medicines Prasugrel and Clopidogrel (each given with aspirin) in patients who had an acute coronary syndrome. It was open to patients who had a recent unstable angina/non-ST-elevation myocardial infarction event with high-risk features. Sponsored by Eli Lilly and Company, the study was conducted in Phase 3 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
+648
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Key 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 Key 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