Comparison of Cypher Select and Taxus Express Coronary Stents

Phase 4

Completed

• Conditions: Coronary Artery Disease; Angina Pectoris
• Interventions: Device: Drug eluting stent

• Registration Number: NCT00388934
• Lead Sponsor: Aarhus University Hospital Skejby

Brief Summary

Randomized nine months clinical comparison of implantation of Taxol eluting (Taxus Express) and Sirolimus eluting (Cypher Select) stents in non-selected patients with coronary artery disease.

Detailed Description

Design:

* Randomized open multicentre trial.

Patients:

* 1800 patients with coronary artery disease scheduled for percutaneous coronary intervention with stent implantation.

Inclusion criteria:

* Patients with coronary artery disease scheduled for percutaneous coronary intervention with stent implantation.

* Signed informed consent.

Exclusion criteria:

* Participation in other stent studies.

Randomization:

* Implantation of Taxus Express og Cypher Select stents.

Primary end-point:

* Combined end-point of cardiac death, new revascularization (PCI or CABG) or myocardial infarction after nine months.

Secondary end-points:

* Total death after nine months

* Cardiac death after nine months

* Myocardial infarction after nine months

* Index vessel myocardial infarction after nine months

* Target lesion revascularization

* Target vessel revascularization

* Stent thrombosis after nine months

End-point evaluation:

* End-points will be adjudicated by an independent end-point committee

Study Timeline

• Study Start: 2004-08
• Primary Completion: 2006-01
• Study First Submitted: 2006-10-16
• Study First Submitted QC: 2006-10-16
• Study First Posted: 2006-10-17
• Status Verified: 2007-05
• Study Completion: 2009-01
• Last Update Submitted: 2013-07-29
• Last Update Posted: 2013-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2095

Inclusion Criteria

• Planned implantation of drug eluting stent
• Written informed consent

Exclusion Criteria

• Planned intervention with other stents than study stents

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Drug eluting stent (Cypher)	Drug eluting stent	Percutaneous coronary intervention with implantation of drug eluting coronary stent (Cypher)
Drug eluting stent (Taxus)	Drug eluting stent	Percutaneous coronary intervention with implantation of drug eluting coronary stent (Taxus)

Primary Outcome Measures

Name	Time	Method
MACE (cardiac death, myocardial infarction, target vessel revascularisation, target lesion revascularisation, TVF)	during 9 months

Secondary Outcome Measures

Name	Time	Method
Total death	after 9 months, 2 and 3 years
Cardiac death	after 9 months, 2 and 3 years
Myocardial infarction	after 9 months, 2 and 3 years
Target vessel revascularisation, target lesion revascularisation, TVF	after 9 months, 2 and 3 years
Stent thrombosis	after 9 months, 2 and 3 years