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news.Daiichi Sankyo and Eli Lilly & Co. have announced plans to begin a new large Phase III clinical trial of prasugrel in the second quarter of 2008. The 10,000 patient study will compare the investigational oral antiplatelet agent with clopidogrel for the management of acute coronary syndrome.
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Daiichi Sankyo Company, and Eli Lilly and Company, which are co-developing prasugrel, will conduct the study in conjunction with the Duke Clinical Research Institute (DCRI). Lead study investigator is Magnus Ohman, professor of cardiology at Duke University School of Medicine.
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. TRILOGY ACS will evaluate the safety and efficacy of prasugrel against clopidogrel in reducing the risk of cardiovascular death, heart attack or stroke in acute coronary syndrome (ACS) patients who are to be medically managed without planned revascularization (a procedure to reopen blocked arteries).
John Alexander, global head of R&D, Daiichi Sankyo Company, said: “The announcement of this study demonstrates our continued confidence in the clinical research surrounding prasugrel.”