“The DAPT Study is a unique study designed to guide medical practice regarding the duration of dual antiplatelet therapy following a drug-eluting stent placement. A large randomized trial is required to provide definitive information, and the completion of enrollment is a major accomplishment toward this goal,” said Laura Mauri, M.D., principal investigator of the DAPT Study, an interventional cardiologist at the Brigham and Women's Hospital and Harvard Medical School in Boston, MA and chief scientific officer of Harvard Clinical Research Institute. “The rate of enrollment into the trial was higher than anticipated, as a result of enthusiastic clinical site participation worldwide. We remain on-target to announce the final Study results in late 2014.”
Dr. Mauri and Dean Kereiakes, M.D., co-principal investigator of the DAPT Study, 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, will both give presentations relevant to the DAPT Study at the Transcatheter Cardiovascular Therapeutics 2011 conference:
• Dr. Mauri will deliver a lecture titled, “Pharmacotherapeutic Considerations to Reduce Stent Thrombosis II: DAPT Duration 6 vs. 12 vs. 24 Months – Review of Completed Trials and Insights from the DAPT Trial Enrollment,” on November 7th
• Dr. Mauri will also give a presentation called, "The DAPT Conundrum: The Trial and the Issues,” on November 10th
• Dr. Kereiakes will give a presentation called, “Dual Antiplatelet Therapy Conundrums: Loading, Duration, Agents and Point-of-Care Testing,” on November 10th
Approximately 26,000 total patients were enrolled into the Study and into the participating manufacturers’ contributing studies, with over 5,000 patients having been randomized to-date. Clinical sites within the United States contributed 90% of the total patients enrolled. The top-enrolling investigators, by region, for the DAPT Study were: Dr. Lowell Satler of Washington Hospital Center (United States), Dr. Jaroslow Trebecz of Beluga-Med Cardiology Centre (European Union), and Dr. Scott Harding of Wellington Hospital and Dr. Peter Thompson of Sir Charles Gairdner Hospital (Australia/New Zealand).
The DAPT Study is being 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/Efient® (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.
DAPT Study Protocol
The DAPT (dual antiplatelet therapy) Study is assessing the benefit of 12 versus 30 months of dual antiplatelet therapy for preventing stent thrombosis and major adverse cardiovascular and cerebrovascular events (MACCE) in subjects undergoing percutaneous coronary intervention (PCI) with drug-eluting stent placement for the treatment of coronary artery lesions. The trial is a four-year, prospective, randomized, double-blind trial evaluating subjects being treated with a drug-eluting stent (DES) or a bare metal stent (BMS) at over 200 centers worldwide. All subjects will receive 12 months of open-label thienopyridine/antiplatelet treatment in addition to aspirin. After 12 months, subjects who are free from all MACCE or major bleeding events will be randomized 1:1 to either placebo or ongoing dual antiplatelet therapy for an additional 18 months followed by three months of observational follow-up. Both arms will continue aspirin therapy. The choice of stent type and thienopyridine drug will be at the discretion of the patient and physician.
The co-primary endpoints for this trial are the incidence of the composite of all death, myocardial infarction (MI) and stroke (referred to as major adverse cerebral and cardiovascular events, or MACCE) between 12 and 33 months post-drug-eluting stent procedure and the incidence of stent thrombosis (ST) between 12 and 33 months post-stent procedure. The primary safety endpoint for this trial is incidence of major bleeding between 12 and 33 months post-drug-eluting stent procedure. The study will also include an adjusted comparison of patients treated with BMS compared with DES on varying durations of antiplatelet therapy.
More information about the DAPT Study is available at www.DAPTStudy.org and the DAPT Study protocol and patient eligibility information are available on www.clinicaltrials.gov.
About The Harvard Clinical Research Institute (HCRI)
The Harvard Clinical Research Institute is a non-profit academic research organization with unparalleled access to resources in clinical research. The Institute advances the research of pharmaceutical, biological, and medical device products by developing collaborations between industry and academia. HCRI’s partners include leading medical centers with worldwide recognition for high-quality medical care and state-of-the-art facilities. Its close affiliation with Harvard Medical School, Beth Israel Deaconess Medical Center and Partners HealthCare reinforces HCRI’s commitment to engaging distinguished medical practitioners in thought-provoking, industry-sponsored research. The Institute’s sponsors rely on its scientific objectivity to add unique value to the design of their studies, oversight of their research and analysis of their study data. As a leading provider of clinical trial services, HCRI plays an important role in assessing new products that improve the quality of peoples’ lives.
www.hcri.harvard.edu
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