About - FAQ

What is the goal of the DAPT Study?
Who is conducting the study?
What companies are participating in the DAPT Study?
Why is the DAPT Study important?
How many patients will be enrolled?
Where will the trial sites be located?
How can my clinical site join the DAPT Study?
When will the results from the study be available?
How can I receive progress updates on how the study is going?

What is the goal of the DAPT Study?

The goal of the DAPT Study is to bring clarity to the global medical community regarding the benefits of 12 versus 30 months of dual antiplatelet therapy in preventing stent thrombosis and major adverse cardiovascular and cerebrovascular events (MACCE) in PCI patients treated with drug-eluting stents. back up

Who is conducting the study?

Harvard Clinical Research Institute is the academic research organization that is responsible for the scientific management and independent analysis of the DAPT Study results. The initiative for the DAPT Study came in response to a U.S. FDA request for post-market studies that would yield sufficient data to determine the benefits of 12 versus 30 months of dual antiplatelet therapy following implantation of a drug-eluting stent. This resulted in a unique collaboration amongst the U.S. FDA, drug and device manufacturers and Harvard Clinical Research Institute. back up

What companies are participating in the DAPT Study?

A group of drug-eluting stent and antiplatelet therapy manufacturers are collaborating with the Harvard Clinical Research Institute and providing funding for the DAPT Study (in alphabetical order): Abbott, Boston Scientific Corporation, Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership, Cordis Corporation, Eli Lilly and Company and Daiichi Sankyo Company Limited, and Medtronic, Inc. back up

Why is the DAPT Study important?

There is currently a lack of data within the international scientific community investigating the use of dual antiplatelet therapy for over one year following a drug-eluting stent (DES) placement. As a result, considerable uncertainty exists about whether the duration of dual antiplatelet therapy in patients receiving DES should be 12 months (as per the ACC/AHA guidelines) or longer in patients without contraindication. To provide data to answer this critical public health question, the U.S. FDA has asked the manufacturers of U.S. FDA-approved DES to conduct a postmarket study to investigate whether patients should continue dual antiplatelet therapy for more than one year following DES implantation. back up

How many patients will be enrolled?

The trial will be a four-year, prospective, randomized, double-blind trial that is expected to enroll over 15,000 subjects being treated with a drug-eluting stent (DES) at over 200 sites in the U.S., E.U., Australia and New Zealand. A cohort of approximately 5,000 subjects treated with a bare metal stent (BMS) will also be enrolled. back up

Where will the trial sites be located?

There are expected to be over 200 sites in the U.S., Czech Republic, France, Germany, Hungary, Poland, Romania, United Kingdom, Australia and New Zealand that will participate in this study. A current listing of participating clinical sites is available at www.clinicaltrials.gov. back up

How can my clinical site join the DAPT Study?

Clinical sites that are interested in participating in the DAPT Study should contact Ann Marie Mercando at the Harvard Clinical Research Institute. back up

When will the results from the study be available?

The DAPT Study is expected to last over four years. Several milestones for enrollment and randomization will be met along the way, but the final results will be based on endpoints that occur after all subjects have been followed for the full treatment period. back up

How can I receive progress updates on how the study is going?

The final DAPT Study results will be based on endpoints that occur after all subjects have been followed for the full treatment period which will be at least four years from the start of the trial in October 2009. Periodic updates and information regarding scientific presentations and publications from the DAPT Study investigators will be posted to the www.DAPTStudy.org website under News and Events. back up