Comparison of Cypher Select and Taxus Express Coronary Stents (SORT-OUTII)

This study has been completed.

Sponsor:

Collaborators:

University of Aarhus

University of Copenhagen

Odense University Hospital

Information provided by:

Skejby Hospital

ClinicalTrials.gov Identifier:

NCT00388934

First received: October 16, 2006

Last updated: March 26, 2010

Last verified: May 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

October 16, 2006

Last Updated Date

March 26, 2010

Start Date ^ICMJE

August 2004

Primary Completion Date

January 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

MACE (cardiac death, MI, TVR, TLR, TVF) [ Time Frame: during 9 months ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

MACE (cardiac death, MI, TVR, TLR, TVF)during 9 months

Change History

Complete list of historical versions of study NCT00388934 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Total death [ Time Frame: after 9 months, 2 and 3 years ] [ Designated as safety issue: Yes ]
Cardiac death [ Time Frame: after 9 months, 2 and 3 years ] [ Designated as safety issue: Yes ]
MI [ Time Frame: after 9 months, 2 and 3 years ] [ Designated as safety issue: Yes ]
TVL, TVR, TVF [ Time Frame: after 9 months, 2 and 3 years ] [ Designated as safety issue: Yes ]
Stent thrombosis [ Time Frame: after 9 months, 2 and 3 years ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Total death after 9 months, 2 and 3 years
Cardiac death after 9 months, 2 and 3 years
MI after 9 months, 2 and 3 years
TVL, TVR, TVF after 9 months, 2 and 3 years
Stent thrombosis after 9 months, 2 and 3 years

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Comparison of Cypher Select and Taxus Express Coronary Stents

Official Title ^ICMJE

Randomized Clinical Comparison of Cypher Select and Taxus Express Stent Implantation in Unselected Patients With Coronary Artery Disease.

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 conscent.

Exclusion critteria:

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-påoints:

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 ajudicated by an independent end-point committee

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Coronary Artery Disease
Angina Pectoris

Intervention ^ICMJE

Procedure: Percutaneous coronary intervention (PCI)

Implantation of coronary stent

Other Names:

PCI
PTCA

Study Arm (s)

Experimental: Cypher
Percutan intervention with Implantation of coronary stent

Intervention: Procedure: Percutaneous coronary intervention (PCI)
Experimental: Taxus
Implantation of coronary stent

Intervention: Procedure: Percutaneous coronary intervention (PCI)

Publications *

Galløe AM, Thuesen L, Kelbaek H, Thayssen P, Rasmussen K, Hansen PR, Bligaard N, Saunamäki K, Junker A, Aarøe J, Abildgaard U, Ravkilde J, Engstrøm T, Jensen JS, Andersen HR, Bøtker HE, Galatius S, Kristensen SD, Madsen JK, Krusell LR, Abildstrøm SZ, Stephansen GB, Lassen JF; SORT OUT II Investigators. Comparison of paclitaxel- and sirolimus-eluting stents in everyday clinical practice: the SORT OUT II randomized trial. JAMA. 2008 Jan 30;299(4):409-16.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

2095

Completion Date

January 2009

Primary Completion Date

January 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Planned implantation of drug eluting stent
Written informed consent

Exclusion Criteria:

Planned intervention with other stents than study stents

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00388934

Other Study ID Numbers ^ICMJE

SORT-OUT II

Has Data Monitoring Committee

Yes

Responsible Party

Department of Cardiology B, Aarhus University Hospital Skejby

Study Sponsor ^ICMJE

Skejby Hospital

Collaborators ^ICMJE

University of Aarhus
University of Copenhagen
Odense University Hospital

Investigators ^ICMJE

Principal Investigator:

Anders Galloe, MD

Gentofte Hospital, Copenhagen

Information Provided By

Skejby Hospital

Verification Date

May 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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