Problem Recent ACS
Format Double-blinded multi-center RCT
Treatment Rivaroxaban 2.5/5mg
Control Placebo
Population 15,526 patients
Inclusion criteria The study included patients (≥18 years of age) who had presented with symptoms suggestive of an acute coronary syndrome and in whom an ST-segment elevation myocardial infarction (STEMI), a non–ST-segment elevation myocardial infarction (NSTEMI), or unstable angina had been diagnosed. Patients who were under 55 years of age had either diabetes mellitus or a previous myocardial infarction in addition to the index event.
Exclusion criteria Key exclusion criteria included a platelet count of less than 90,000 per cubic millimeter, a hemoglobin level of less than 10 g per deciliter, or a creatinine clearance of less than 30 ml per minute at screening; clinically significant gastrointestinal bleeding within 12 months before randomization; previous intracranial hemorrhage; and previous ischemic stroke or transient ischemic attack in patients who were taking both aspirin and a thienopyridine.
Follow-up Mean of 13 months
Primary endpoint Composite of death from cardiovascular causes, myocardial infarction, or stroke
Secondary endpoint(s) Death from any cause, myocardial infarction, or stroke
Details Patients were randomly assigned in a 1:1:1 fashion to twice-daily administration of either 2.5 mg or 5.0 mg of rivaroxaban or placebo, with a maximum follow-up of 31 months. All patients were to receive standard medical therapy, including low-dose aspirin; they were to receive a thienopyridine (either clopidogrel or ticlopidine) according to the national or local guidelines. Randomization was stratified on the basis of planned use of a thienopyridine. Patients were then to be seen at 4 weeks, at 12 weeks, and thereafter every 12 weeks.
Brief summary: Rivaroxaban post-ACS reduced death/MI/CVA but increased non-fatal bleeding
PAPER: Rivaroxaban in Patients with a Recent Acute Coronary Syndrome
Date 13 Nov 2011
Journal N Engl J Med. 2011 Nov 13. [Epub ahead of print]
Information Enrollment occurred within 7 days
-All patients stabilised prior to starting
-All revasc. etc. completed

Reduced the risk of the composite of death from CV causes, myocardial infarction, or stroke

Increased risk of minor, major bleeding and intracranial hemorrhage (p=<0.001
-Trend towards lower major risk in 2.5mg (vs 5mg)
No increased risk of fatal bleeding (p=0.66)