Subscribe: Latest / All - Designed by Dr James P Howard (Google+)
ATLAS-ACS-2-TIMI-51 TRIAL |
|
|---|---|
| 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) |