EDUCATE: The MEDTRONIC Endeavor Drug Eluting Stenting: Understanding Care, Antiplatelet Agents and Thrombotic Events
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Intervention: Placebo Arm; Thienopyridine Therapy; Surveillance Arm
Intervention description: Placebo and ASA (75 mg - 325 mg); Prasugrel 5 or 10 mg or Clopidogrel 75 mg plus ASA (75 mg - 325 mg); Non randomized arm to understand clinical outcomes in a commercial setting
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 2272.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No
Keywords: Heart Disease; Cardiovascular Disease; Platelet Aggregation Inhibitors; Dual Antiplatelet Therapy; Clopidogrel; Prasugrel; Vascular Disease; Myocardial Ischemia

Summary:

      EDUCATE is a prospective, multi-center study designed to collect real-world safety and
      clinical outcomes in subjects receiving one or more Endeavor Zotarolimus-Eluting Stents and
      either clopidogrel and aspirin or prasugrel and aspirin as part of a dual antiplatelet
      therapy (DAPT) drug regimen.
    

Eligibility criteria:

        ENROLLMENT INCLUSION CRITERIA

          -  Patient is older than 18 years.

          -  The patient or patient's legal representative has consented to participate and has
             authorized the collection and release of his medical information by signing the
             "Subject Informed Consent Form".

          -  Patients undergoing percutaneous intervention with Endeavor stent deployment (or has
             within 24 hours).

          -  The patient is willing and able to cooperate with study procedures and required follow
             up visits.

        ENROLLMENT EXCLUSION CRITERIA

          -  Index procedure stent placement with stent diameter < 2.5 mm or > 3.5 mm.

          -  Pregnant women.

          -  Current medical condition with a life expectancy of less than 3 years.

          -  The patient is currently participating in another investigational device or drug study
             that clinically interferes with the EDUCATE Study. The patient may only be enrolled in
             the EDUCATE Study once.

          -  Patients with hypersensitivity or allergies to one of the drugs or components
             indicated in the Instructions for Use.

          -  Patients in whom anti-platelet and/or anticoagulation therapy is contraindicated.

          -  Patients treated with any stent other than the Endeavor stent during the index
             procedure.

        RANDOMIZATION INCLUSION CRITERIA AT 12 MONTHS

          -  Subject is "12 Month Clear".

          -  Subjects without known contraindication to dual antiplatelet therapy for at least 18
             months after randomization.

        RANDOMIZATION EXCLUSION CRITERIA AT 12 MONTHS

          -  Pregnant women.

          -  Subject switched thienopyridine type or dose within 6 months prior to randomization.

          -  Planned surgery necessitating discontinuation of antiplatelet therapy within the 18
             months following randomization.

          -  Percutaneous coronary intervention or cardiac surgery between 6 weeks post index
             procedure and randomization.

          -  Planned surgery necessitating discontinuation of antiplatelet therapy within the 21
             months following randomization.

          -  Current medical condition with a life expectancy of less than 3 years.

          -  Subjects on warfarin or similar anticoagulant therapy.