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The study, TRILOGY ACS (TaRgeted platelet Inhibition to cLarify theOptimal strateGy to medicallY manage Acute Coronary Syndromes), will includeapproximately 10,000 patients at more than 800 hospitals in 35 countries.
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Daiichi Sankyo Company, Limited (TSE: 4568) and Eli Lilly and Company(NYSE: LLY), which are co-developing prasugrel, will conduct the study inconjunction with the Duke Clinical Research Institute (DCRI), the world'slargest academic clinical research organization and a part of Duke UniversityMedical Center. Lead study investigator is E. Magnus Ohman, M.D., Professor ofCardiology at Duke University School of Medicine.
About TRILOGY ACS
The study is a multi-center, double-blind, randomized, controlled trialthat will include approximately 10,000 patients, with about 800 hospitals in35 countries participating. TRILOGY ACS will evaluate the safety and efficacyof prasugrel against clopidogrel in reducing the risk of cardiovascular death,heart attack or stroke in ACS patients who are to be medically managed withoutplanned revascularization (a procedure to reopen blocked arteries). Currently,more than 50 percent of patients presenting with ACS worldwide are managedwithout acute intervention.
"TRILOGY ACS, which will be one of the largest of its kind, will be a veryimportant study as it will focus on a group of medically managed patients withACS who have not been extensively studied in the past," said lead studyinvestigator E. Magnus Ohman, M.D., Professor of Cardiology at Duke UniversitySchool of Medicine.
When patients present with ACS, their symptoms are secondary to a lack ofadequate oxygen delivery to the heart, usually due to a significant narrowingor blockage of one or more of the coronary arteries due to plaque. This plaquehas the potential to rupture at any time and cause an arterial clot (thrombus)to form, which can block oxygenated blood from reaching the heart muscle.Antiplatelet medications help to reduce the incidence of this acute thrombusformation.
"The announcement of this study demonstrates our continued confidence inthe clinical research surrounding prasugrel," said John Alexander, M.D.,M.P.H., global head of research and development, Daiichi Sankyo Company,Limited.
About cardiovascular disease
Cardiovascular disease is the leading cause of death in the U.S. andworldwide, killing 16.7 million people each year(2). Acute heart attacks andunstable angina, called acute coronary syndrome, affect more than 840,000Americans each year and 800,000 in Europe(3,4). Even with current medicalinterventions, 300,000 people experience recurrent heart attacks and 500,000people die from heart attacks annually in the United States(5).
About prasugrel
Daiichi Sankyo Company, Limited (TSE: 4568), and Eli Lilly and Company(NYSE: LLY) are co-developing prasugrel, an investigational oral antiplateletagent invented by Daiichi Sankyo and its Japanese research partner UbeIndustries, Ltd., as a potential treatment, initially for patients with acutecoronary syndrome undergoing PCI. Prasugrel works by inhibiting plateletactivation and subsequent aggregation by blocking the P2Y12 adenosinediphosphate (ADP) receptor on the platelet surface. Antiplatelet agentsprevent platelets from clumping or sticking together, which can result inclogged arteries and may lead to heart attack or stroke.
About Daiichi Sankyo Company, Limited
Daiichi Sankyo Company, Limited, established
