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U.S. Department of Health and Human Services

Science & Research

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The Dual Antiplatelet Therapy Study

Critical Path Drives Unique Collaboration to Improve Patient Safety 


Fatal heart attacks strike about one American a minute. And of the 785,000 Americans who had a heart attack in 2009, approximately 470,000 can expect to have another, according to the CDC. 

Medicine has come a long way in treating heart disease, the leading cause of death in the United States and a chief cause of disability. Today, some 700,000 U.S. patients suffering from heart disease benefit from artery-opening devices, called drug-eluting stents. Implanted into narrowed, diseased arteries, these stents slowly release an anti-inflammatory drug to prevent the regrowth of tissue that could block the stented artery.

Drug-eluting stents have proven much more effective in reducing the need for a repeat procedure than implantation with bare metal stents. But FDA is concerned about rare, but deadly, cases in which blood clots form after the stents have been in place for a time, causing heart attack—even death. 

Clinical experts agree that treating heart patients with a combination of aspirin and thienopyridine—known as dual antiplatelet therapy—can reduce such risks.  Yet long-term use of the antiplatelet drugs brings its own risks, including bleeding complications. 

What physicians want to know is how long patients should undergo antiplatelet drug therapy to improve the safety of the implanted stents, considering the possible bleeding side effects of the antiplatelet drugs. 

To tackle this major public health question, FDA's Critical Path Initiative spearheaded an unprecedented collaboration, bringing together four device and four drug manufacturers to participate with regulators, clinical investigators, and academia in a four-year, 20,000-patient study in 220 clinical trial centers in North America and Europe. 

Launched in September 2009, under the management of Harvard Clinical Research Institute, the study is comparing two different durations of treatment with aspirin plus antiplatelet drugs (12 months vs. 30 months on the antiplatelet medication while continuing on aspirin). 

By leveraging the shared resources of all participants, this study will give the global medical community the information it needs to devise appropriate treatment recommendations for the duration of antiplatelet therapy in patients with drug-eluting stents, thus improving the safety of patients who receive these implants.