Problem Acute Coronary Syndrome
Format -
Treatment Vorapaxar
Control Placebo
Population 12,944 patients
Inclusion criteria -
Exclusion criteria -
Follow-up STOPPED EARLY - Median 502 days
Primary endpoint Composite of death from cardiovascular causes, myocardial infarction, stroke, recurrent ischemia with rehospitalization, or urgent coronary revascularization
Secondary endpoint(s) Composite of death from cardiovascular causes, myocardial infarction, or stroke.
Details Patients were eligible if they had had acute symptoms of coronary ischemia within 24 hours before hospital presentation and at least one of the following findings: a cardiac troponin (I or T) or creatine kinase MB (CK-MB) level that was higher than the upper limit of the normal range or new ST-segment depression of more than 0.1 mV or transient ST-segment elevation (<30 minutes) of more than 0.1 mV in at least two contiguous leads. Also required were one or more of the following four criteria: an age of at least 55 years; previous myocardial infarction, PCI, or coronary-artery bypass grafting (CABG); diabetes mellitus; or peripheral arterial disease. A complete list of inclusion and exclusion criteria is provided in the Supplementary Appendix. All patients provided written informed consent.
Brief summary:
PAPER: Thrombin-Receptor Antagonist Vorapaxar in Acute Coronary Syndromes
Date 13 Nov 2011
Journal N Engl J Med. 2011 Nov 13. [Epub ahead of print]
Information N.B. STOPPED EARLY

No significant reductions in primary endpoint
(composite of death from CV causes,MI ,stroke, recurrent ischemia with rehospitalization/urgent coronary revasc)

Significantly increased the risk of major bleeding, including intracranial hemorrhage