Conditions: Acute Coronary Syndrome Myocardial Infarction Myocardial Ischemia Unstable Angina
Keywords: Rivaroxaban Acute Coronary Syndrome ACS Aspirin Thienopyridine Unstable Angina Myocardial Infarction Anticoagulation Clopidogrel (Plavix)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 15526
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine whether rivaroxaban in addition to standard care reduces the risk of the composite of cardiovascular death, myocardial infarction, or stroke in patients with a recent acute coronary syndrome compared with placebo.

Detailed description:
Acute coronary syndrome (ACS) is a serious and life threatening condition. Following an acute coronary syndrome event patients are at risk of important additional clinical events such as death, myocardial infarction, and stroke. Six months after patients present with an index event of ST-segment myocardial infarction, approximately 15% will either have died or had another episode of myocardial ischemia, and a similar situation exists for non-ST-segment elevation myocardial infarction/unstable angina patients. This randomized; double-blind; placebo controlled study will evaluate the efficacy and safety of rivaroxaban in addition to standard care in patients with a recent ACS. Patients will be given rivaroxaban (2.5 mg twice daily or 5 mg twice daily) or placebo (twice daily) in addition to standard care.

Arms:
arm 1: One 2.5 mg rivaroxaban tablet twice daily for up to 6 months arm 2: One 5 mg rivaroxaban tablet twice daily for up to 6 months arm 3: One placebo tablet twice daily for up to 6 months

Interventions: intervention 1: Rivaroxaban 2.5 mg intervention 2: Rivaroxaban 5 mg intervention 3: Placebo intervention 4: Standard of care
Intervention descriptions: intervention 1: One tablet twice daily intervention 2: One tablet twice daily intervention 3: One placebo tablet twice daily intervention 4: None

Protocol document: