In Landmark Phase III Head-to-Head Study, Prasugrel Statistically Superior to Clopidogrel in Reducing Risk of He...(results to help us further tailor prasug...),Health

Cardiovascular disease is the leading cause of death in the U.S. and worldwide, killing 16.7 million people each year(i). Acute heart attacks and unstable angina, called acute coronary syndrome, affect more than 840,000 Americans each year and 800,000 in Europe(i,ii). Utilizing current medical interventions and treatments, 300,000 people continue to experience recurrent heart attacks and 450,000 people die from heart attacks annually in the U.S(iv).

"TRITON confirms the statistically superior clinical benefit of prasugrel as a third-generation oral antiplatelet that may advance cardiovascular care," said John Alexander, M.D., M.P.H., global head of research and development, Daiichi Sankyo Company, Limited. "Given the promising TRITON results, Daiichi Sankyo and Lilly are expeditiously finalizing our submission package and are still hopeful to submit to the FDA by year end."

About the TRITON TIMI-38 study

TRITON TIMI-38 was a Phase III, multi-center, randomized, double blind, parallel group, head-to-head clinical trial comparing the effects of prasugrel versus 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 and non-fatal stroke during a median period of at least 12 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 t
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