CYPRESS - CYPHER for Evaluating Sustained Safety

NCT ID: NCT00954707

Last Updated: 2014-02-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 2509 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2016-03-31

Brief 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)

Detailed Description

During Phase I (non-randomized phase) of this study, the primary objective is to assess the rate of target lesion failure in subjects implanted with the CYPHER® stent and receiving dual antiplatelet therapy for 12 months.

During Phase II (randomized phase) of this study, the primary objective is to assess safety (major and minor bleeding), MACCE, and ST rates in subjects treated with dual antiplatelet therapy for 12 or 30 months following CYPHER® stent implantation.

*Subjects treated with the CYPHER® 2.25mm stent will be followed through 60 months.

**The last 500 patients enrolled will not be eligible for randomization.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

12m DAPT Group

Group Type: PLACEBO_COMPARATOR

Placebo & Aspirin

Intervention Type: DRUG

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.

30m DAPT Group

Group Type: ACTIVE_COMPARATOR

Clopidogrel & Aspirin, Prasugrel & Aspirin

Intervention Type: DRUG

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.

Interventions

Clopidogrel & Aspirin, Prasugrel & 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 thienopyridine treatment in addition to aspirin.

Intervention Type: DRUG

Placebo & 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 Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

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"

Exclusion Criteria

• 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.

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

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cordis Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Simon, M.D.

Role: PRINCIPAL_INVESTIGATOR

University Hospitals, Case Medical Center (Cleveland)

David Kandzari, M.D.

Role: PRINCIPAL_INVESTIGATOR

Piedmont Hospital, Atlanta, GA

Locations

University Hospitals, Case Medical Center (Cleveland)

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

P09-6301

Identifier Type: -

Identifier Source: org_study_id