Conditions: Acute Coronary Syndrome
Keywords: ACS
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 9326
Healthy volunteers: no

Brief 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).

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.

Arms:
arm 1: Prasugrel and Low-dose Commercially-available Aspirin arm 2: Clopidogrel and Low-Dose Commercially-available Aspirin

Interventions: intervention 1: Clopidogrel intervention 2: Prasugrel intervention 3: Commercially-available Aspirin
Intervention descriptions: intervention 1: 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 2: 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 3: Low-dose aspirin, oral, as prescribed by physician through end of study

Protocol document: