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TRITON-TIMI-38 TRIAL |
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| Problem | ACS with scheduled PCI |
| Format | Randomised, blinded |
| Treatment | Prasugrel |
| Control | Clopidogrel |
| Population | 13608 patients |
| Inclusion criteria | The inclusion criteria for patients with unstable angina or non–ST-elevation myocardial infarction were ischemic symptoms lasting 10 minutes or more and occurring within 72 hours before randomization, a TIMI risk score of 3 or more, and either ST-segment deviation of 1 mm or more or elevated levels of a cardiac biomarker of necrosis. Patients with ST-elevation myocardial infarction could be enrolled within 12 hours after the onset of symptoms if primary PCI was planned or within 14 days after receiving medical treatment for ST-elevation myocardial infarction. |
| Exclusion criteria | Key exclusion criteria included an increased risk of bleeding, anemia, thrombocytopenia, a history of pathologic intracranial findings, or the use of any thienopyridine within 5 days before enrollment. |
| Follow-up | 15 months |
| Primary endpoint | Composite of death from cardiovascular causes, nonfatal MI or nonfatal stroke |
| Secondary endpoint(s) | Key secondary end points at 30 and 90 days were the primary composite end point and a composite of death from cardiovascular causes, nonfatal myocardial infarction, or urgent target-vessel revascularization. Key secondary end points for the entire follow-up period were stent thrombosis and a composite of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or rehospitalization due to a cardiac ischemic event. Additional prespecified analyses included an analysis of the rates of the primary end point from randomization to day 3 and a landmark analysis of those data from day 3 to the end of the study. Key safety end points were TIMI major bleeding not related to coronary-artery bypass grafting (CABG), non–CABG-related TIMI life-threatening bleeding, and TIMI major or minor bleeding, as previously defined. |
| Details | . |
| Brief summary: | Prasugrel superior to clopidogrel in ACS scheduled for PCI |
| PAPER: Prasugrel versus Clopidogrel in Patients with Acute Coronary Syndromes | |
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| Date | 15 Nov 2007 |
| Journal | N Engl J Med. 2007 Nov 15;357(20):2001-15. Epub 2007 Nov 4. |
| Information | Prasugrel (vs. clopidogrel) -Significant reduction --Composite of death from cardiovascular causes, nonfatal MI or nonfatal stroke --MI --Urgent target vessel revascularisation --Stent thrombosis -Increased risk of bleeding -Increased risk of life-threatening bleeding |