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TRACER TRIAL |
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|---|---|
| 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 |