The Harvard Clinical Research Institute (HCRI) has expanded its DAPT study, a four-year clinical trial that will investigate the effectiveness of dual-antiplatelet therapy (DAPT) to reduce blood clots following drug-eluting stent (DES) implantations, to Australia and New Zealand.
The trial will compare the benefits of a 12-month versus 30-month dose of DAPT—aspirin and a thienopyridine/antiplatelet therapy—in patients undergoing PCI with DES to treat coronary artery lesions.
The current American College of Cardiology (ACC) and the American Heart Association (AHA) guidelines recommend 12 months of DAPT for patients undergoing PCI following the placement of a DES.
The study’s principal investigator, Laura Mauri, MD, of the Brigham and Women’s Hospital and Harvard Medical School in Boston, and colleagues will record the benefits of the 12- and 30-month therapy to prevent stent thrombosis and major adverse cardiovascular and cerebral events (MACCE) in patients undergoing PCI.
The trial, initiated in the U.S. in 2009 and Europe in 2010, will enroll 15,000 patients at 200 international centers. An estimated 5,000 of these patients will be treated with a bare-metal stent (BMS) and the rest with DES. After 12 months of the DAPT, subjects will be randomized at a 1:1 ratio to receive either placebo or ongoing DAPT.
“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 U.S. and EU is another important milestone toward reaching our goal of enrolling approximately 20,000 subjects in this important large, randomized controlled trial," Mauri said.