Dual antiplatelet therapy study expanded into Australia and New Zealand

Oct 26 2010

The Harvard Clinical Research Institute (HCRI) announced today that the DAPT Study has expanded into Australia and New Zealand. Professor Ian Meredith, MBBS, Ph.D., interventional cardiologist at MonashHeart in Melbourne, Australia and National Coordinating Investigator for the DAPT Study in Australia, was the first Pacific Rim investigator to enroll patients into the study. Enrollment into the DAPT Study was initiated in the United States in October 2009 and in the European Union in May 2010.

“There is a significant need for a large randomized trial like the DAPT Study to evaluate the appropriate duration of dual antiplatelet therapy, in order to answer these important questions.”

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 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 American College of Cardiology/ American Heart Association currently recommend 12 months of dual antiplatelet therapy for patients undergoing percutaneous coronary intervention (PCI) following placement of a drug-eluting stent.

Principal investigator of the DAPT Study, Laura Mauri, M.D., 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, said, "The global scope of the DAPT Study demonstrates the significant interest on the part of clinicians worldwide in answering this critical question on the benefits and the risks associated with prolonged dual antiplatelet therapy beyond one year following a stent procedure. The addition of Australia and New Zealand to the ongoing DAPT Study efforts in the US and EU is another important milestone toward reaching our goal of enrolling approximately 20,000 subjects in this important large, randomized controlled trial."

"Stent thrombosis is a potentially devastating complication of coronary artery stenting, and significant uncertainty currently exists amongst clinicians worldwide regarding the risks of stent thrombosis as compared to the potential bleeding risks associated with prolonged dual antiplatelet therapy," said Professor Meredith. "There is a significant need for a large randomized trial like the DAPT Study to evaluate the appropriate duration of dual antiplatelet therapy, in order to answer these important questions."

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.