Dual-antiplatelet therapy trial begins enrollment

The Harvard Clinical Research Institute (HCRI) has reported that the first patients have been enrolled in the DAPT [dual-antiplatelet therapy] Study, marking the official initiation of the four-year clinical trial to investigate the duration of dual-antiplatelet therapy following drug-eluting stent (DES) implantations.

The public health study is powered to evaluate the benefits of 12 versus 30 months of dual-antiplatelet therapy in patients receiving DES to address coronary artery lesions.

The first patients were enrolled into the DAPT trial by co-principal investigator Dean J. Kereiakes, MD, 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 in Cincinnati.

The DAPT trial will be conducted through a public-private collaboration involving HCRI, four stent manufacturers: Abbott (Xience V), Boston Scientific (Taxus, Promus), Cordis (Cypher), and Medtronic (Endeavor); the manufacturers of thienopyridine/antiplatelet medications: Bristol-Myers Squibb/Sanofi Aventis Pharmaceuticals Partnership (Plavix or clopidogrel) and Eli Lilly and Daiichi-Sankyo (Effient or prasugrel); and the FDA.

HCRI, which is responsible for the scientific management of the DAPT trial and the independent analysis of the resulting data, received funding support from each of the drug and device manufacturers.

Principal investigator Laura Mauri, MD, a cardiologist at Brigham and Women's Hospital in Boston and chief scientific officer of HCRI, said, "[C]urrent guidelines call for patients who are treated with DES 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."

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