Clinical trial NCT00954707: CYPRESS - CYPHER for Evaluating Sustained Safety
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: Atherosclerosis
Lead sponsor: Cordis Corporation
Sponsor class: INDUSTRY
First posted: 2009-08-07
Enrollment: 2509
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Phase I: the Rate of Target Lesion Failure (TLF)
timeFrame: 12 months
Secondary outcomes:
measure: Rate of Device Success
timeFrame: From post- procedure to hospital discharge, up to 39 days
measure: Rate of Lesion Success
timeFrame: From post- procedure to hospital discharge, up to 39 days
measure: Rate of Procedure Success
timeFrame: From post- procedure to hospital discharge, up to 39 days
measure: Rate of Clinically-driven Target Lesion Revascularization (TVR)
timeFrame: 12 Months
measure: Rate of Clinically Driven Target Vessel Revascularization (TVR)
timeFrame: 12 months
measure: Rate of Target Vessel Failure (TVF)
timeFrame: 12 Months
measure: Rate of Major Adverse Cardiac Events (MACE)
timeFrame: 12 Months
measure: Rate of Protocol Defined Stent Thrombosis (ST)
timeFrame: 12 Months
measure: Rate of Academic Research Consortium (ARC) Defined Stent Thrombosis (ST)
timeFrame: 12 Months
measure: Rate of Protocol Defined Major Bleeding Complications
timeFrame: 12 Months
measure: Rate of Cardiac Death
timeFrame: 12 Months
measure: Rate of Non-cardiac Death
timeFrame: 12 Months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals, Case Medical Center (Cleveland)
state: Ohio
Study officials:
affiliation: University Hospitals, Case Medical Center (Cleveland)
name: Daniel Simon, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Piedmont Hospital, Atlanta, GA
name: David Kandzari, M.D.
role: PRINCIPAL_INVESTIGATOR
References: