For Media

FAQ

What is the goal of the DAPT Study?
Please give an overview of the trial protocol?
How many patients will be enrolled?
Who is conducting the study?
What companies are participating in the DAPT Study?
Why is the DAPT Study important?
When will the trial be completed? Are there any interim data points before the final results?
When will the results from the study be available?
How is the trial being funded?
Who is responsible for working with FDA?
What other dual antiplatelet therapy duration trials are being conducted? How is the DAPT Study different from the others?

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 to top

Please give an overview of the trial protocol?

The DAPT Study will assess the safety and effectiveness of 12 versus 30 months of dual antiplatelet therapy for preventing stent thrombosis and major adverse cardiovascular and cerebrovascular events (MACCE) in subjects undergoing percutaneous coronary intervention (PCI) with drug-eluting stent placement for the treatment of coronary artery lesions. back to top

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 to top

Who is conducting the study?

Harvard Clinical Research Institute (HCRI) is responsible for the overall scientific conduct of the study and the independent analysis of the resulting data. back to top

What companies are participating in the DAPT Study?

A group of drug-eluting stent and antiplatelet therapy manufacturers are collaborating with HCRI 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 to top

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 placement. As a result, considerable uncertainty exists about whether the duration of dual antiplatelet therapy in patients receiving drug-eluting stents 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 drug-eluting stent implantation. back to top

When will the trial be completed? Are there any interim data points before the final results?

The 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. The Data Monitoring Board (DMB) will meet regularly during the study to review study data, but that information will remain confidential to the public. back to top

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 to top

How is the trial being funded?

The trial is being funded by the cooperative agreement of eight manufacturers (four major stent manufacturers and four manufacturers of antiplatelet medications) who came together to address a U.S. FDA request for post-marketing studies that will yield sufficient data to identify the optimal duration of dual anti-platelet therapy following PCI and implantation of drug-eluting stents. However, the scientific design, data collection and final analysis will be independently managed by Harvard Clinical Research Institute (HCRI). back to top

Who is responsible for working with U.S. FDA?

Harvard Clinical Research Institute (HCRI) is the sole holder of the DAPT Study’s Investigational Device Exemption (IDE). HCRI is working directly with the U.S. FDA Center for Devices and Radiological Health (CDRH). CDRH is consulting with the Center for Drug Evaluation and Research (CDER) to ensure that the trial design and proposed operations are acceptable given the involvement of the U.S. FDA-approved thienopyridine drugs. back to top

What other dual antiplatelet therapy duration trials are being conducted? How is the DAPT Study different from the others?

A number of studies examining optimal duration of dual antiplatelet therapy following drug-eluting stent placement are currently being conducted globally. Some randomized studies are examining the duration of 12 months versus of longer treatment, as is the DAPT Study. Some randomized studies are alternately examining the duration of 12 months versus a shorter treatment. While each of these studies adds complementary information, the DAPT Study is distinguished by its size and scope, and has sufficient power to compare both co-primary endpoints of stent thrombosis and clinical events. back to top