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Harvard’s DAPT study moves into Australia

The DAPT Study (Dual Anti-Platelet Therapy) – a four-year clinical trial investigating the duration of dual anti-platelet therapy following drug-eluting stent (DES) implantations – is to be expanded into Australia.

15 Nov 2010

The DAPT Study (Dual Anti-Platelet Therapy) – a four-year clinical trial investigating the duration of dual anti-platelet therapy following drug-eluting stent (DES) implantations – is to be expanded into Australia.

Enrolment in DAPT started in the US in October last year and in the European Union in May this year. Adding Australia (and New Zealand) will help organisers - the Harvard Clinical Research Institute (HCRI) – to enroll 20,000 participants, which will make DAPT seriously large. Prof Ian Meredith, the interventional cardiologist at MonashHeart, is the National Coordinating Investigator in Australia.

The goal of DAPT is to work out the benefits and risks associated with prolonged dual anti-platelet therapy beyond one year after a stent procedure.

DAPT will be a prospective, randomised double-blind trial of at least 15,000 patients being treated with a DES, plus about 5,000 treated with a bare metal stent (BMS) at more than 200 centres worldwide.

The organisers have recruited four major stent manufacturers to take part – Abbott (XIENCE V), Boston Scientific Corporation (TAXUS, PROMUS), Cordisn Corporation (CYPHER) and Medtronic (ENDEAVOR) - plus three drug manufacturers – the Bristol Myers/Squibb/Sanofi partnership, Eli Lilley and Daiichi Sankyo.

DAPT has received funding support from all these companies.

Prof Meredith says that there is considerable uncertainty among clinicians worldwide about the risks of stent thrombosis compared to the potential bleeding risks associated with prolonged dual anti-platelet therapy and therefore a significant need for a large study like DAPT to answer their questions.

Information about study protocol and patient eligibility can be found at www.clinicaltrials.gov


Published: 15 Nov 2010