Industry Post-Stenting Antiplatelet Trial Gains $1.5 Million Boost From FDA
This article was originally published in The Pink Sheet Daily
Executive Summary
Study aims to identify optimum duration of anti-clotting drugs for stent patients; enrollment targeted at 20,000 patients.
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FDA is contributing $1.5 million to a large, collaborative clinical study designed to find out the optimum duration of anti-clotting drugs in patients with coronary drug-eluting stents. The 20,000-patient dual antiplatelet therapy trial (DAPT), announced in October, will likely cost upwards of $100 million, with most of the funds coming from industry. The four major drug-eluting stent manufacturers are teaming up with Plavix (clopidogrel) marketers Sanofi-Aventis and Bristol-Myers Squibb' and just-approved Effient (prasugrel) sponsors Lilly and Daiichi Sankyo (Also see "Effient Labeling Could Give Edge Against Plavix Through Pharmacogenetics" - Pink Sheet, 10 Jul, 2009.) as well as FDA and the Harvard Clinical Research Institute (Also see "High Hopes For Stent Antiplatelet Therapy Trial" - Medtech Insight, 20 Oct, 2008.). The study is not intended as a head-to-head comparison of the different stents and drugs. Individual product results will only be disclosed to FDA and the investigators. The $1.5 million, disclosed in a July 8 FDA funding opportunity announcement, will be awarded to study-leader HCRI by the agency's Office of Critical Path Programs. The DAPT study is "unprecedented" for the significant collaboration it has attracted between the industry players, the government and academic researchers, FDA says in the funding notice. Combining forces will save money and provide a quicker answer to a vexing question within the cardiology community, it says. Cardiologists have been rethinking their approach to drug-eluting stent treatment in response to a growing awareness of the potential for patients to experience a thrombosis event in a stented artery more than a year after device placement. There is widespread agreement about the need to extend the antiplatelet course beyond the 3-to-6 months prescribed in the original FDA drug-eluting stent approvals, but how long is up for debate. Professional guidelines now recommend 12 months of aspirin and a thienopyridine, but many cardiologists believe an even longer regimen increases safety. The DAPT trial will compare a 12-month to a 30-month course; it is also enrolling patients with bare-metal stents in addition to those with drug-eluting stents to determine if benefit from extended dual antiplatelet treatment is specific to the latter. Primary support for the trial will come from stent-makers Johnson & Johnson/Cordis ( Cypher ), Boston Scientific ( Taxus and Promus ), Medtronic ( Endeavor ) and Abbott ( Xience ) as well as the four drug companies. -David Filmore ([email protected]) |