CYPRESS - CYPHER for Evaluating Sustained Safety

NCT00954707 | Unknown Phase 4 Results DMC

• 1 other identifier: P09-6301
• Study Type: interventional
• Target: 2,509
• Locations: 1 country
• Sites: 1

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)

Conditions

Coronary Artery Disease

Keywords

Atherosclerosis

Outcome Measures

Primary Outcomes (1)

• Phase I: the Rate of Target Lesion Failure (TLF)

  Target lesion failure (TLF) is defined as clinically-driven target lesion revascularization, target vessel myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vessel at 12 months.

  12 months

Secondary Outcomes (12)

• Rate of Device Success

  From post- procedure to hospital discharge, up to 39 days

• Rate of Lesion Success

  From post- procedure to hospital discharge, up to 39 days

• Rate of Procedure Success

  From post- procedure to hospital discharge, up to 39 days

• Rate of Clinically-driven Target Lesion Revascularization (TVR)

  12 Months

• Rate of Clinically Driven Target Vessel Revascularization (TVR)

  12 months

Study Arms (2)

12m DAPT Group

PLACEBO COMPARATOR

Drug: Placebo & Aspirin

30m DAPT Group

ACTIVE COMPARATOR

Drug: Clopidogrel & Aspirin, Prasugrel & Aspirin

Interventions

Clopidogrel & Aspirin, Prasugrel & Aspirin 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.

30m DAPT Group

Placebo & Aspirin 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.

12m DAPT Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Subjects must meet the following criterion to be eligible for randomization in the study:
• Subject is 12 Month Clear

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cordis US Corp.: lead

Study Sites (1)

University Hospitals, Case Medical Center (Cleveland)

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease; Atherosclerosis

Interventions

Clopidogrel; Aspirin; Prasugrel Hydrochloride

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines

Results Point of Contact

• Title: Amy Orlick, Associate Director
• Organization: Cordis Corporation, a Johnson & Johnson company

aorlick@its.jnj.com

908-541-4347

Study Officials

• Daniel Simon, M.D.

  University Hospitals, Case Medical Center (Cleveland)

  PRINCIPAL INVESTIGATOR

• David Kandzari, M.D.

  Piedmont Hospital, Atlanta, GA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2009
• First Posted: August 7, 2009
• Study Start: August 1, 2009
• Primary Completion: January 1, 2012
• Study Completion: March 1, 2016
• Last Updated: February 7, 2014
• Results First Posted: October 9, 2013

Record last verified: 2014-01

Locations

US (1)