Jan. 19, 2007 — Daiichi Sankyo Co., Ltd. and Eli Lilly and Co. have announced completion of patient enrollment in their pivotal Phase III head-to-head clinical study — TRITON TIMI-38 — to evaluate the safety and efficacy of prasugrel compared with clopidogrel (Plavix) in patients with acute coronary syndrome undergoing percutaneous coronary intervention (PCI).
Elliott Antman, M.D., director of the Samuel A. Levine Cardiac Unit at Brigham and Women's Medical Center is the study’s lead investigator and senior investigator in the TIMI Study Group.
Specifically, the Phase III study is designed to evaluate the safety and efficacy of prasugrel compared with clopidogrel in reducing ischemic events such as heart attacks, stroke and death in patients with acute coronary syndrome undergoing PCI. The trial is being conducted in conjunction with the TIMI Study Group at Harvard Medical School and Brigham and Women's Hospital in Boston.
Patient enrollment began in November 2004 and has reached a total enrollment of 13,614 patients at more than 700 trial sites in 30 countries. In the U.S. more than 4,063 patients have been enrolled at 313 trial sites, and in Europe, 2,178 patients have been enrolled at 132 sites.
For more information visit www.daiichisankyo.co.jp/eng and www.lilly.com.