Daiichi Sankyo, Lilly Announce New Prasugrel Head-to-Head Phase III Study Against Clopidogrel

Duke Clinical Research Institute to lead multinational study with investigational compound

06-Nov-2007

A large Phase III clinical trial is anticipated to begin in the second quarter of 2008 to compare the effects of prasugrel, an investigational oral antiplatelet agent, against clopidogrel (Plavix(R)/Iscover(R)) in medically managed patients with Acute Coronary Syndrome (ACS), a group of common heart conditions that includes unstable angina (chest pain) and heart attacks(1).

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 Company, Limited and Eli Lilly and Company, which are co-developing prasugrel, will conduct the study in conjunction with the Duke Clinical Research Institute (DCRI), part of Duke University Medical Center. Lead study investigator is E. Magnus Ohman, M.D., Professor of Cardiology at Duke University School of Medicine.

Daiichi Sankyo Company, Limited and Eli Lilly and Company are co-developing prasugrel, an investigational oral antiplatelet agent invented by Daiichi Sankyo and its Japanese research partner Ube Industries, Ltd., as a potential treatment, initially for patients with acute coronary syndrome undergoing 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 can result in clogged arteries and may lead to heart attack or stroke.

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