Ph III prasugrel trial completes enrollment

Japanese drugmaker Daiichi Sankyo and US drug major Eli Lilly have completed patient enrollment in a pivotal Phase III head-to-head study - TRITON TIMI-38 - to evaluate the safety and efficacy of prasugrel compared with Sanofi-Aventis and Bristol-Myers Squibb's co-marketed anti-clotting drug Plavix (clopidogrel) in patients with acute coronary syndrome undergoing percutaneous coronary intervention.

The Phase II TRITON TIMI-38 clinical trial is being conducted in conjunction with the TIMI Study Group at Harvard Medical School and is designed to evaluate the safety and efficacy of prasugrel versus Plavix in reducing ischemic events such as heart attacks, stroke and death in patients with acute coronary syndrome undergoing PCI, a procedure to open blockages in heart arteries that includes the use of coronary stents.

According to the firm, patient enrollment began in November 2004 and has reached a total of 13,614 subjects at more than 700 trial sites in 30 countries. In the USA, more than 4,063 patients have been enrolled at 313 trial sites, while in Europe, there have been 2,178 at 132 sites.