CYPRESS - CYPHER for Evaluating Sustained Safety
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Intervention: Clopidogrel & Aspirin, Prasugrel & Aspirin; Placebo & Aspirin
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 thienopyridine 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 18 months of placebo treatment in addition to 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, Investigator, Outcomes Assessor)
Enrollment: 2509.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Atherosclerosis

Summary:

      CYPRESS: A Prospective,Randomized,Multi-Center,Double-Blind Trial to Assess the Effectiveness
      and Safety of Different Durations of Dual Anti-Platelet Therapy (DAPT) in Subjects Undergoing
      Percutaneous Coronary Intervention with the CYPHER® Sirolimus-eluting Coronary Stent (CYPHER®
      Stent)
    

Eligibility criteria:

        DAPT Group - Inclusion Criteria:

        Phase I: Enrollment Inclusion Criteria

        Subjects must meet ALL of the following inclusion criteria to be enrolled in the study:

          -  The subject must be 18 years of age.

          -  Subjects undergoing percutaneous intervention with stent deployment

          -  Subjects without known contraindication to dual antiplatelet therapy for at least 30
             months after enrollment and stent implantation.

          -  The subject or Legally Authorized Representative has consented to participate and has
             authorized the collection and release of his/her medical information by signing the
             "Patient Informed Consent Form" that is approved by the Institutional Review Board or
             Independent Ethics Committee. The informed consent will be valid for the duration of
             the trial or until the subject withdraws.

        DAPT Group Phase II: Randomization Inclusion Criterion at 12 months

        Subjects must meet the following criterion to be eligible for randomization in the study:

          -  Subject is 12 Month Clear

        DAPT Group - Exclusion Criteria:

        Phase I: Enrollment Exclusion Criteria

        Subjects will be excluded if ANY of the following exclusion criteria apply:

          -  Index procedure requiring use of a stent with a nominal diameter < 2.25 mm or > 3.5
             mm.

          -  Pregnant women.

          -  Planned (at time of enrollment) 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 where the primary endpoint has
             not been reached or the device/drug might affect major endpoint outcomes in either
             Phase I or Phase II of the study.

          -  The subject may only be enrolled in the 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.

          -  Subjects unable to give informed consent.

          -  Subject treated with both DES and BMS during the index procedure.

        DAPT Group Phase II: Randomization Exclusion Criteria at 12 months

        Subjects will be excluded from randomization if any of the following criteria are met:

          -  Pregnant women.

          -  Subject switched thienopyridine type within 6 months prior to randomization

          -  Percutaneous coronary interventions 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 subsequent warfarin or similar anticoagulant therapy.

          -  Subjects who do not receive any CYPHER® Stent during the index procedure.

        Non-DAPT Group

        The following inclusion and exclusion criteria are for the Non-DAPT subjects. These
        criteria will be used to determine if the subject meets the near on-label definition

        Non-DAPT Group - Inclusion Criteria:

        Subjects must meet ALL of the following criteria to be enrolled in this study:

          1. The subject must be ≥18 years of age

          2. Index procedure requiring use of a stent with a nominal diameter 2.25mm to 3.5mm

          3. Lesion Length ≤ 34mm

          4. Up to 2 lesions in up to 2 vessels (2 in one vessel or 1 in each of 2 vessels)

          5. Ejection fraction > 30%

          6. Target lesion stenosis is >50% and <100% (visual estimate)

          7. Female of childbearing potential must have a negative pregnancy test within 10 days
             prior to enrollment

          8. The subject or Legally Authorized Representative has consented to participate and has
             authorized the collection and release of his/her medical information by signing the
             "Patient Informed Consent Form"

        Non-DAPT Group - Exclusion criteria

        And must NOT meet any of the following exclusion criteria:

          1. Target Lesion includes Bifurcations with side branch diameter >2.5mm

          2. Patient with excessive calcified/angulated lesion that is not suitable for stenting in
             the Investigator's opinion

          3. Restenotic Target Lesion previously treated with a stent

          4. Greater than 2 overlapping stents used to treat target lesion.

          5. Target Lesion within an unprotected Left Main (LM) with ≥50% stenosis

          6. Target Lesion within a coronary bypass graft (e.g., saphenous vein or arterial graft)

          7. Chronic (> 3 months) Total Occlusion (CTO) Lesions, TIMI grade 0 or 1 in the target
             lesion

          8. ST segment Elevation Myocardial Infarction (STEMI) within 30 days or non-STEMI within
             72 hours

          9. Renal insufficiency (creatinine >2.5 mg) or dialysis dependent

         10. Lesion with visible clot

         11. Patient with prior brachytherapy

         12. Documented left ventricular ejection fraction is ≤30%

         13. Pretreatment with devices other than conventional balloon angioplasty

         14. Recipient of heart transplant

         15. Subject with a life expectancy less than 1 year

         16. Known allergies to the following: aspirin, all commercially available anti-platelet
             drugs heparin, stainless steel, contrast agent (that cannot be managed medically), or
             sirolimus (that cannot be managed medically);

         17. Any significant medical condition which, in the Investigator's opinion, may interfere
             with the subject's optimal participation in the study;

         18. Currently participating in an investigational drug or device study that has either not
             completed the primary endpoint where the prior study drug/device might affect this
             study's primary endpoint

         19. In the Investigator's opinion, the lesion is not suitable for stenting.

         20. Known bleeding or hypercoagulable disorder;

         21. Known or suspected active infection at the time of the study procedures;

         22. Subject is known to be pregnant

         23. Subject is a prisoner, mentally incompetent, and/or alcohol or drug abuser;

         24. Planned (at the time of enrollment) surgery necessitating discontinuation of
             anti-platelet therapy within the twelve (12) months following enrollment.