Abstract | BACKGROUND: STUDY DESIGN: TRITON-TIMI 38 is a phase 3, randomized, double-blind, parallel-group, multinational, clinical trial. Approximately 13,000 patients with moderate to high-risk ACS undergoing PCI (9500 unstable angina/non- ST-segment elevation myocardial infarction [MI], 3500 ST-segment elevation MI) will be randomized to prasugrel 60 mg loading dose followed by 10 mg daily or clopidogrel 300 mg loading dose followed by 75 mg daily for up to 15 months. The primary end point is the time of the first event of cardiovascular death, MI, or stroke. Analyses will be performed first in the unstable angina/non-ST-segment elevation MI cohort and, conditionally, on the whole ACS population. Major safety end points include TIMI major and minor bleeding unrelated to coronary artery bypass graft surgery. CONCLUSIONS: TRITON-TIMI 38 is a phase 3 comparison of prasugrel versus clopidogrel in patients with moderate to high-risk ACS undergoing PCI. In addition, it is the first large-scale clinical events trial to assess whether a thienopyridine regimen that achieves a higher level of inhibition of platelet aggregation than the standard therapy results in an improvement in clinical outcomes.
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Authors | Stephen D Wiviott, Elliott M Antman, C Michael Gibson, Gilles Montalescot, Jeffrey Riesmeyer, Govinda Weerakkody, Kenneth J Winters, Jeffrey W Warmke, Carolyn H McCabe, Eugene Braunwald, TRITON-TIMI 38 Investigators |
Journal | American heart journal
(Am Heart J)
Vol. 152
Issue 4
Pg. 627-35
(Oct 2006)
ISSN: 1097-6744 [Electronic] United States |
PMID | 16996826
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Piperazines
- Platelet Aggregation Inhibitors
- Thiophenes
- Clopidogrel
- Prasugrel Hydrochloride
- Ticlopidine
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Topics |
- Acute Disease
- Aged
- Angioplasty, Balloon, Coronary
(adverse effects)
- Clopidogrel
- Coronary Disease
(drug therapy, therapy)
- Dose-Response Relationship, Drug
- Double-Blind Method
- Follow-Up Studies
- Humans
- Myocardial Infarction
(drug therapy)
- Piperazines
(administration & dosage, therapeutic use)
- Platelet Aggregation Inhibitors
(administration & dosage, therapeutic use)
- Prasugrel Hydrochloride
- Research Design
- Syndrome
- Thiophenes
(administration & dosage, therapeutic use)
- Thrombolytic Therapy
- Thrombosis
(prevention & control)
- Ticlopidine
(administration & dosage, analogs & derivatives, therapeutic use)
- Treatment Outcome
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