For Patients

General Information

The DAPT Study is an independent, large-scale study in size and scope intended to investigate the benefits of 12 versus 30 months of dual antiplatelet therapy (aspirin and a second anti clotting medicine taken by mouth in pill form) to protect patients from stent-related blood clots and other major adverse cardiovascular events following the implantation of drug-eluting coronary stents (DES).

What are drug eluting stents and how/why are they used?
A diagnosis with a condition called myocardial ischemia means that there is a blockage in one of the heart arteries that narrows the passageway through the artery and limits the amount of blood flow to the heart muscle. When blood flow is limited, less oxygen gets to the heart muscle and this causes symptoms, such as chest pain and shortness of breath. A compete blockage may result in heart attack. Medical devices known as stents (a hollow metal tube) are commonly placed to open the blockage in the heart artery in a medical procedure known as percutaneous coronary intervention (PCI).

The purpose of the DAPT Study is to collect information about how dual antiplatelet therapy following a PCI keeps you free from death, heart attack, stroke, bleeding, blood clots and the need to perform another PCI. PCI procedures are performed either with a drug-eluting stent (DES) which is coated with a drug that helps prevent the blockage from coming back, or with a bare metal stent (BMS), a stent that is not coated with drug. All of the stents that will be used in the DAPT Study have already been approved by the U.S. Food and Drug Administration (FDA) for use in people.

Why is the DAPT Study needed if the stents being used are already U.S. FDA approved? DES are a widely accepted and generally safe treatment option for a blocked artery for most patients. Current treatment guidelines call for patients who get a DES to remain on dual antiplatelet therapy for at least one year, in order to prevent blood clots from forming. However, in rare instances, dangerous clots can form in the devices more than year after they are implanted, leading some physicians to consider prescribing dual antiplatelet therapy for longer periods of time to prevent later adverse events from occurring.

The U.S. FDA has requested that stent and drug makers conduct a large-scale public health study to determine whether DES patients receive benefit from taking dual antiplatelet therapy for longer than one year. The DAPT Study will address this important question by comparing the benefits of 12 months versus 30 months of treatment following the placement of a coronary stent. The study will examine whether there is any benefit in prevention of death, heart attack or stroke with longer treatment. It will also examine whether there is any increase in risk of bleeding with longer treatment.

The outcome of this four-year study will help to bring clarity to the global medical community regarding how long patients should be treated with dual antiplatelet therapy after receiving a DES.

More information about the DAPT Study can be found on the ClinicalTrials.gov website at www.clinicaltrials.gov. Patients with specific questions or concerns about their current care and treatment are encouraged to address these with their physician.

Clinical Trial Sites

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.