The Dual Antiplatelet Therapy Study (DAPT Study)
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Intervention: Placebo & Aspirin; Clopidogrel & Aspirin, Prasugrel & Aspirin
Intervention MeSH terms: Aspirin; Clopidogrel; Prasugrel Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 25682.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Acute Coronary Syndrome; Adverse event; Antiplatelet therapy; Sirolimus; Everolimus; Paclitaxel; Zotarolimus; Bare Metal Stent; Drug Eluting Stent; Clinical Events Committee; Dual antiplatelet therapy; Harvard Clinical Research Institute; Major Adverse Cardiac and Cerebral Event; Major Bleeding; Myocardial infarction; Myocardial ischemia; Percutaneous coronary intervention; Stent placement; Stent Thrombosis; Thienopyridine; Clopidogrel; Prasugrel

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.
    

Eligibility criteria:

        Inclusion Criteria (Enrollment):

          1. Subject is > 18 years of age.

          2. Subjects undergoing percutaneous intervention with stent deployment (or has w/in 24
             hours).

          3. Subjects without known contraindication to dual antiplatelet therapy for at least 30
             months after enrollment and stent implantation.

          4. 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.

        Inclusion Criterion (Randomization at 12 months):

        1. Subject, at 12 months, is free from death, MI, stroke, repeat coronary
        revascularization, major bleeding, and stent thrombosis and has been compliant with dual
        antiplatelet therapy following stent implantation.

        Exclusion Criteria (Enrollment):

          1. Index procedure stent placement with stent diameter <2.25 mm or >4.0 mm.

          2. Pregnant women.

          3. Planned surgery necessitating discontinuation of antiplatelet therapy within the 30
             months following enrollment.

          4. Current medical condition with a life expectancy of less than 3 years.

          5. 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.

          6. Subjects on warfarin or similar anticoagulant therapy.

          7. Subjects with hypersensitivity or allergies to one of the drugs or components
             indicated in the Instructions for Use for the device implanted.

          8. Subjects unable to give informed consent.

          9. Subject treated with both DES and BMS during the index procedure.

        Exclusion Criteria (Randomization at 12 months):

          1. Pregnant women.

          2. Subject switched thienopyridine type or dose within 6 months prior to randomization.

          3. Percutaneous coronary intervention or cardiac surgery between 6 weeks post index
             procedure and randomization.

          4. Planned surgery necessitating discontinuation of antiplatelet therapy within the 21
             months following randomization.

          5. Current medical condition with a life expectancy of less than 3 years.

          6. Subjects on warfarin or similar anticoagulant therapy.