HCRI commences patient enrollment in dual antiplatelet therapy study

The Harvard Clinical Research Institute (HCRI) announced today that the first patients have been enrolled in the DAPT Study, marking the official initiation of the four-year clinical trial to investigate the duration of dual antiplatelet therapy (DAPT, the combination of aspirin and a thienopyridine/antiplatelet medication to reduce the risk of blood clots) following drug-eluting stent implantations. The large-scale public health study is expected to bring clarity to the global medical community regarding the benefits of 12 versus 30 months of dual antiplatelet therapy in patients receiving drug-eluting stents to address coronary artery lesions. The first patients were enrolled into the DAPT Study by co-principal investigator, Dean J. Kereiakes, M.D., medical director of The Christ Hospital Heart and Vascular Center and The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital, Cincinnati, Ohio.

The DAPT Study will be conducted through a public-private collaboration involving HCRI, four major stent manufacturers: Abbott (XIENCE V^®), Boston Scientific Corporation (TAXUS^®, PROMUS^®), Cordis Corporation (CYPHER^®), Medtronic, Inc. (Endeavor^®); the manufacturers of thienopyridine/antiplatelet medications: Bristol-Myers Squibb Company/Sanofi Pharmaceuticals Partnership (Plavix^®(clopidogrel bisulfate)) and Eli Lilly and Company and Daiichi-Sankyo Company Limited (Effient™ (prasugrel)); and the U.S. Food and Drug Administration (FDA). HCRI, which is responsible for the scientific management of the DAPT Study and the independent analysis of the resulting data, received funding support from each of the drug and device manufacturers.

"This study is the first postmarket investigation in which the FDA brought together industry competitors who put aside competition and achieved an unprecedented level of cooperation with regulators and academia to answer a major public health question," said FDA Commissioner Margaret A. Hamburg, M.D.

Principal investigator, Laura Mauri, M.D., a cardiologist at the Brigham and Women's Hospital in Boston, MA and chief scientific officer of Harvard Clinical Research Institute said, "Current guidelines call for patients who are treated with drug-eluting stents to remain on blood-thinning medications for at least one year, but some physicians continue prescribing medications considerably longer in hopes of preventing very late stent thrombosis. The DAPT Study will enroll a broad spectrum of patients treated with stents and will look at both stent-related and patient-related outcomes to help define an appropriate course of therapy following placement of a drug-eluting stent."

"Drug-eluting stents are a widely accepted and generally safe treatment option for opening up a blocked artery. However, in rare instances, clots can form in the devices well past a year after they are implanted – after the currently recommended period of dual antiplatelet therapy use," said Dr. Kereiakes. "Because patients will be followed for almost three years for both stent-related and clinical outcomes, the DAPT Study results will be instrumental in establishing the standard of care following a drug-eluting stent procedure."

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