FDA Contributes Funds To Industry Post-Stenting Antiplatelet Trial

The 20,000-patient dual antiplatelet therapy trial announced in October and slated to start enrolling patients this fall, likely will cost upward of $100 million, with most of the funds coming from industry.

FDA is contributing $1.5 million to a large, collaborative clinical study designed to find out the optimum length of time to give anti-clotting drugs to patients with coronary drug-eluting stents.

The 20,000-patient dual antiplatelet therapy trial (DAPT), announced in October and slated to start enrolling patients this fall, 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 Bristol-Myers Squibb and Sanofi-Aventis, marketers of Plavix (clopidogrel), and Eli Lilly and Daiichi Sankyo, makers of the just-approved Effient (prasugrel) (Also see "High Hopes For Stent Antiplatelet Therapy Trial" - Medtech Insight, 20 Oct, 2008.).

The $1.5 million contribution, 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 collaboration it has attracted among industry, government and academic researchers, FDA says in the funding notice. Combining forces will save money and provide a quicker answer to a vexing question in the cardiology space, the agency 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 thrombotic event in a stented artery more than a year after device placement.

Extending antiplatelet regimens has been a core part of that process. Professional guidelines now recommend 12 months of aspirin and a thienopyridine anti-clotting drug following drug-eluting stent placement, up from the three to six months recommended in the original Cypher and Taxus labeling. But many cardiologists believe an even longer treatment course increases safety (Also see "Confusion Over Anti-Clotting Therapy Hinders Drug-Eluting Stent Rebound" - Medtech Insight, 29 Oct, 2007.).

DAPT will compare a 12-month regimen to a 30-month regimen. It is also enrolling patients with bare-metal stents along with those with drug-eluting stents to see if any benefit from extended dual antiplatelet treatment is specific to the latter.

-David Filmore ([email protected])

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