Overview

This trial is active, not recruiting.

Condition coronary artery disease
Treatments clopidogrel & aspirin, prasugrel & aspirin, placebo & aspirin
Phase phase 4
Sponsor Cordis Corporation
Start date August 2009
End date January 2012
Trial size 2509 participants
Trial identifier NCT00954707, P09-6301

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)

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
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.
(Active Comparator)
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.

Primary Outcomes

Measure
Phase I: the Rate of Target Lesion Failure (TLF)
time frame: 12 months

Secondary Outcomes

Measure
Rate of Device Success
time frame: From post- procedure to hospital discharge, up to 39 days
Rate of Lesion Success
time frame: From post- procedure to hospital discharge, up to 39 days
Rate of Procedure Success
time frame: From post- procedure to hospital discharge, up to 39 days
Rate of Clinically-driven Target Lesion Revascularization (TVR)
time frame: 12 Months
Rate of Clinically Driven Target Vessel Revascularization (TVR)
time frame: 12 months
Rate of Target Vessel Failure (TVF)
time frame: 12 Months
Rate of Major Adverse Cardiac Events (MACE)
time frame: 12 Months
Rate of Protocol Defined Stent Thrombosis (ST)
time frame: 12 Months
Rate of Academic Research Consortium (ARC) Defined Stent Thrombosis (ST)
time frame: 12 Months
Rate of Protocol Defined Major Bleeding Complications
time frame: 12 Months
Rate of Cardiac Death
time frame: 12 Months
Rate of Non-cardiac Death
time frame: 12 Months

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title 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)
Principal investigator Daniel Simon, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by Cordis Corporation.