Conditions: Atherosclerosis Myocardial Ischemia Myocardial Infarction
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 12944
Healthy volunteers: no

Brief summary:
The study is designed to determine whether vorapaxar, when added to the existing standard of care (eg, aspirin, clopidogrel) for preventing heart attack and stroke in patients with acute coronary syndrome, will yield additional benefit over the existing standard of care in preventing heart attack and stroke.

The study is also designed to assess risk of bleeding with vorapaxar added to the standard of care versus the standard of care alone.

Detailed description:

Arms:
arm 1: Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care. arm 2: Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.

Interventions: intervention 1: Vorapaxar intervention 2: Placebo
Intervention descriptions: intervention 1: oral tablets; 40-mg loading dose on first day, followed by 2.5 mg once daily for at least 1 year intervention 2: oral tablets; matching placebo for vorapaxar; loading and maintenance dosing; once daily for at least 1 year

Protocol document: