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Study Results Show Investigational Drug, Prasugrel, Cuts Risk of Stent-Related Clots by More than Half Versus Clopidogrel
Date:3/29/2008

91 percent, p=0.04).

"The reduction in risk seen in patients in this analysis treated with prasugrel over patients treated with clopidogrel is encouraging for high-risk patients with acute coronary syndrome being managed with PCI," said J. Anthony Ware, M.D., Lilly vice president for cardiovascular/acute care.

About the TRITON-TIMI 38 stent analysis

TRITON-TIMI 38 was a Phase III, multi-center, randomized, double blind, parallel group, head-to-head clinical trial comparing the effects of prasugrel vs. clopidogrel in patients with acute coronary syndrome undergoing percutaneous coronary intervention (PCI). PCI is a procedure to open blockages in heart arteries including the use of coronary stenting. The study enrolled 13,608 patients at 707 trial sites in 30 countries.

The primary endpoint of the study was to compare the effects of prasugrel to clopidogrel on the composite incidence of cardiovascular death, non-fatal heart attack, or non-fatal stroke during a median period of 14.5 months following PCI. Key secondary objectives included rehospitalization for a cardiac ischemic event; the need for additional procedures to restore blood flow (urgent target vessel revascularization) at 30 days; and stent thrombosis. Key safety endpoints included non-CABG major, life threatening and minor bleeding as well as the overall safety and tolerability of prasugrel.

Patients were randomly assigned to one of two treatment groups and given a loading dose of either prasugrel 60 mg or the approved loading dose of clopidogrel 300 mg anytime between randomization and one hour after the completion of the PCI procedure, followed by a daily maintenance dose of either prasugrel 10 mg or clopidogrel 75 mg. All patients also received a daily low dose of aspirin.

Subjects enrolled in TRITON were included in the stent analysis if they received at least one coronary stent at randomization and were further subdivided based on the types of stents received.
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SOURCE Eli Lilly and Company
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