For Patients

FAQ

What is the goal of the DAPT Study?
Why is the DAPT Study important - why is it needed?
Who is conducting the study?
What companies are participating in the DAPT Study?
How many patients will be enrolled?
What is the time commitment for patients who are participating in the study?
Where will the trial sites be located?
Why is the use of bare metal stents included in this study? Isn’t the primary concern with DES?
Should patients enrolled in the DAPT Study worry about being put on the longer duration of dual antiplatelet therapy? Are there any safety concerns?

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 (aspirin and a second blood thinning medicine taken by mouth in pill form) in preventing stent-related blood clots and major adverse cardiovascular and cerebrovascular events (MACCE) in percutaneous coronary intervention (PCI) patients treated with drug-eluting stents. back to top

 

Why is the DAPT Study important- why is it needed?

There is currently a lack of data within the international scientific community investigating the use of dual antiplatelet therapy for over one year following drug-eluting stent (DES) placement. As a result, considerable uncertainty exists in the medical community 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 post-market study to investigate whether patients should continue dual antiplatelet therapy for more than one year following DES implantation. back to top

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 DAPT Study is an international initiative that came in response to an 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 FDA, drug and device manufacturers and Harvard Clinical Research Institute. back to top

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 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

What is the time commitment for patients who are participating in the study?

Patients will be asked to be followed up for up to 33 months after the stent placement procedure. Patients participating in the study should ask their doctor to explain which follow-up will be required of them. back to top

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. The most up-to-date information on clinical trial sites that are enrolling patients can be found at www.clinicaltrials.gov. back to top

Why is the use of bare metal stents included in this study? Isn’t the primary concern with DES?

The primary concern of the DAPT Study is the duration of dual anti-platelet therapy (DAPT) in subjects treated with drug-eluting stents (DES), but there is also question regarding how long patients with bare metal stents (BMS) should be treated. The inclusion of BMS will allow DES to be compared with the alternative, BMS, after adjusting for duration of therapy and patient characteristics. back to top

Should patients enrolled in the DAPT Study worry about being put on the longer duration of dual antiplatelet therapy? Are there any safety concerns?

All study drugs will be used in a controlled manner and subject safety will be assessed frequently. All clinical trials present risks, and the DAPT Study will be conducted ethically and with subject safety as the paramount concern. Both medications that are being used in the DAPT Study are now approved by the FDA for use in people and the treating physician will have the choice to use whichever drug that they feel will be most beneficial to the patient. Participation in the DAPT Study is completely voluntary. Patients may choose not to be in this study. If a patient does not want to be in the study, they may still receive the same treatment using these devices and medicines. Patients should talk to their doctor about what the best course of treatment is for them. A patient’s future care and their relationship with their doctor will not be affected if they decide not to be in this study. back to top