XIENCE V® USA Dual Antiplatelet Therapy (DAPT) Cohort
Condition: Chronic Total Occlusion of Coronary Artery; Vascular Disease; Myocardial Ischemia; Coronary Artery Stenosis; Coronary Disease; Coronary Artery Disease; Coronary Restenosis
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Vascular Diseases; Coronary Stenosis; Coronary Restenosis; Ischemia
Intervention: placebo + aspirin; clopidogrel + aspirin OR prasugrel + aspirin; XIENCE V Everolimus Eluting Coronary Stent System (XIENCE V EECSS)
Intervention description: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin.; This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin.; XIENCE V Everolimus Eluting Coronary Stent System assigned to both the arms.
Intervention MeSH terms: Aspirin; Everolimus; Clopidogrel; Prasugrel Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 870.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: drug eluting stents; Stents; Angioplasty; Stent thrombosis; antiplatelet treatment

Summary:

      XIENCE V USA is a prospective, multi-center, multi-cohort postapproval study. The objectives
      of this study are

        -  To evaluate XIENCE V EECSS continued safety and effectiveness during commercial use in
           real world settings, and

        -  To support the Food and Drug Administration (FDA) dual antiplatelet therapy (DAPT)
           initiative. This initiative is designed to evaluate the composite of all death,
           myocardial infarction (MI) and stroke (MACCE) and the survival of patients that are free
           from Academic Research Consortium (ARC) definite or probable stent thrombosis (ST) and
           that have been treated with drug eluting stents (DES) and extended dual antiplatelet
           therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who are enrolled into the XIENCE V USA Study Phase I

          -  The patient agrees to participate in this study by signing the Institutional Review
             Board (IRB) approved informed consent form. Alternatively, the patient's legally
             authorized representative agrees to the patient's participation in this study and
             signs the informed consent form.

        Exclusion Criteria:

          -  The inability to obtain an informed consent is an exclusion criterion.

        Patients must meet the following criteria to be eligible for randomization in the study:

          -  Patient is "12 Month Clear": "12-Month Clear" patients are free from death, MI,
             stroke, repeat coronary revascularization, major bleeding - "severe" or "moderate" by
             GUSTO classification, and ST 12 months after stent implantation. Staged PCI is allowed
             (same stent type as index); repeat PCI and peri-procedural myocardial infarction
             occurring with the index procedure or repeat procedure within the first 6 weeks will
             not be considered exclusionary events for the definition of "12 Month Clear".

          -  Patient is "DAPT Compliant": During the open label portion of this study (time 0-12
             months), a patient is considered compliant with the thienopyridine therapy for the
             purposes of eligibility if they take between 80% and 120% of the prescribed drug in a
             given period without an interruption of therapy longer than 14 days. This information
             will be ascertained via data collected at the patient interviews at 6 and 12 months
             post-procedure. Compliance at both time points is required to be considered "clear".

          -  Patient completes 1 year visit within ± 30 days window.

        Patients will be excluded from randomization if any of the following criteria are met:

          -  Pregnant women.

          -  Switched thienopyridine type or dose within 6 months prior to randomization. Note:
             Thienopyridine switching during the open label portion of this study is discouraged.

          -  PCI 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.

          -  Patients on warfarin or similar anticoagulant therapy.