NCT00954707

CYPRESS - CYPHER for Evaluating Sustained Safety

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)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2,509 (actual)
• Sponsor: Cordis US Corp. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	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.
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.

Timeline

• Start date: 2009-08-01
• Primary completion: 2012-01-01
• Completion: 2016-03-01
• First posted: 2009-08-07
• Last updated: 2014-02-07
• Results posted: 2013-10-09

Locations

1 site across 1 country: United States