News | August 09, 2012

Harvard Clinical Research Institute Successfully Completes Randomization in DAPT Study

Landmark study to provide definitive data on duration of dual antiplatelet therapy following drug-eluting stent implantation

August 9, 2012 — The Harvard Clinical Research Institute (HCRI) announced today the successful completion of randomization in the DAPT study, with the total number of patients randomized exceeding the upper goal set for the study. The DAPT study is a four-year clinical trial investigating 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 (DES) implantations.

The large-scale public health study is expected to report on the benefits of 12 versus 30 months of DAPT in patients receiving drug-eluting stents to address coronary artery lesions. The American College of Cardiology/American Heart Association (ACC/AHA) currently recommend 12 months of DAPT for patients undergoing percutaneous coronary interventions (PCI) following placement of a DES.

“The clinical community is awaiting a definite answer as to the appropriate duration of DAPT that balances beneficial long-term outcomes while minimizing bleeding complications. The DAPT study is uniquely designed to answer this question and to draw meaningful conclusions regarding specific risks and benefits, due to its large sample size, statistical power and focus on presenting data from real-world practice,” said Laura Mauri, M.D., principal investigator, chief scientific officer of HCRI, interventional cardiologist at the Brigham and Women’s Hospital and Harvard Medical School in Boston. “We plan to announce final results from the study in late 2014, which we expect will inform future practice guidelines on the duration of DAPT following DES implantation.”

“We are pleased to have successfully enrolled approximately 26,000 patients into the study and into the participating manufacturers’ contributing studies, with approximately 12,000 total patients having been subsequently randomized. The large number of patients involved in the DAPT study is a major strength of the trial, and we are thankful to the over 450 sites throughout the United States, Canada, European Union, Australia and New Zealand that contributed to the study,” added Dean. J. Kereiakes, M.D., co-principal investigator, 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 study is being conducted through a public-private collaboration involving HCRI; four major stent manufacturers (Abbott, Boston Scientific Corp., Cordis Corp. and Medtronic Inc.); the manufacturers of thienopyridine/antiplatelet medications: Bristol-Myers Squibb/Sanofi Pharmaceuticals partnership (clopidogrel bisulfate), and Eli Lilly and Co. and Daiichi Sankyo Co. Ltd. (prasugrel); and the U.S. Food and Drug Administration (FDA).

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