FDA Extends Review Period for Daiichi Sankyo, Lilly Investigative Antiplatelet Drug,...(lexander M.D. M.P.H. global headof resea...),Health

About Trilogy ACS

The study, TRILOGY ACS (TaRgeted platelet Inhibition to cLarify the Optimal strateGy to medicallY manage Acute Coronary Syndromes), will include approximately 10,000 patients at more than 800 hospitals in 35 countries.

Daiichi Sankyo and Lilly are conducting the study in conjunction with the Duke Clinical Research Institute (DCRI), the world's largest academic clinical research organization and a part of Duke University Medical Center.

The study is a multi-center, double-blind, randomized, controlled trial to evaluate the safety and efficacy of prasugrel against clopidogrel in reducing the risk of cardiovascular death, heart attack or stroke in ACS patients who are to be medically managed without a planned artery-opening procedure.

Acute coronary syndromes, which comprises heart attacks and unstable angina (chest pain), affects more than 1.4 million people in the United States annually.(1) Despite currently available treatments, 320,000 people experience recurrent heart attacks each year.(2)

About prasugrel

Daiichi Sankyo Company, Limited (TSE: 4568), and Eli Lilly and Company (NYSE: LLY) are co-developing prasugrel, an investigational oral antiplatelet agent discovered by Daiichi Sankyo and its Japanese research partner, Ube Industries, Ltd., as a potential treatment, initially for patients with acute coronary syndromes who are managed with PCI. Prasugrel works by inhibiting platelet activation and subsequent aggregation by blocking the P2Y12 adenosine diphosphate (ADP) receptor on the platelet surface. Antiplatelet agents prevent platelets from clumping or sticking together, which c
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