The Dual Antiplatelet Therapy Study (DAPT Study) (NCT00977938) | Clinical Trial Compass
CompletedPhase 4
The Dual Antiplatelet Therapy Study (DAPT Study)
United States25,682 participantsStarted 2009-10
Plain-language summary
The DAPT Study is a double blind randomized controlled trial intended to determine the appropriate duration for dual antiplatelet therapy (the combination of aspirin and a second anti-clotting medication) as well as the safety and effectiveness of dual antiplatelet therapy to protect patients from stent thrombosis and major adverse cardiovascular and cerebrovascular events (MACCE) following the implantation of drug-eluting coronary stents. Similar analysis will be conducted in a smaller cohort of bare metal coronary stent - treated subjects.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Subject is \> 18 years of age.
✓. Subjects undergoing percutaneous intervention with stent deployment (or has w/in 24 hours).
✓. Subjects without known contraindication to dual antiplatelet therapy for at least 30 months after enrollment and stent implantation.
✓. The subject has consented to participate and has authorized the collection and release of his medical information by signing the "Patient Informed Consent Form". The informed consent will be valid for the duration of the trial or until the subject withdraws.
Exclusion criteria
✕. Index procedure stent placement with stent diameter \<2.25 mm or \>4.0 mm.
✕. Pregnant women.
✕. Planned surgery necessitating discontinuation of antiplatelet therapy within the 30 months following enrollment.
✕. Current medical condition with a life expectancy of less than 3 years.
✕. Concurrent enrollment in another device or drug study whose protocol specifically excludes concurrent enrollment or that involves blinded placement of a DES or BMS other than those included as DAPT Study devices. The subject may only be enrolled in the DAPT Study once.
✕. Subjects on warfarin or similar anticoagulant therapy.
✕. Subjects with hypersensitivity or allergies to one of the drugs or components indicated in the Instructions for Use for the device implanted.
What they're measuring
1
MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT