The Harvard Clinical Research Institute (HCRI) has stated that the dual antiplatelet therapy (DAPT) study has expanded into Australia and New Zealand.
Enrollment into the DAPT study was initiated in the US in October 2009 and in the EU in May 2010.
HCRI said that the DAPT study is a four-year clinical trial investigating the duration of dual antiplatelet therapy (the combination of aspirin and a thienopyridine/antiplatelet medication to reduce the risk of blood clots) following drug-eluting stent implantations.
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.
DAPT study principal investigator Laura Mauri said that the scope of the study demonstrates the 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 randomised controlled trial,” Mauri said.
DAPT Study national coordinating investigator in Australia Meredith said there is a need for a large randomised 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 collaboration involving HCRI; four major stent manufacturers: Abbott (XIENCE V), Boston Scientific (TAXUS, PROMUS), Cordis (CYPHER), Medtronic (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 (Effient/Efient (prasugrel)); and the US Food and Drug Administration.