Comparison of Cypher Select and Taxus Express Coronary Stents - Full Text View

Sponsor:	Skejby Hospital
Collaborators:	University of Aarhus University of Copenhagen Odense University Hospital
Information provided by:	Skejby Hospital
ClinicalTrials.gov Identifier:	NCT00388934

Purpose

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.

Condition	Intervention	Phase
Coronary Artery Disease Angina Pectoris	Procedure: Percutaneous coronary intervention (PCI)	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Randomized Clinical Comparison of Cypher Select and Taxus Express Stent Implantation in Unselected Patients With Coronary Artery Disease.

Resource links provided by NLM:

MedlinePlus related topics: Angina Coronary Artery Disease

U.S. FDA Resources

Further study details as provided by Skejby Hospital:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Enrollment:	2095
Study Start Date:	August 2004
Study Completion Date:	January 2009
Primary Completion Date:	January 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Cypher Percutan intervention with Implantation of coronary stent	Procedure: Percutaneous coronary intervention (PCI) Implantation of coronary stent Other Names: PCI PTCA
Experimental: Taxus Implantation of coronary stent	Procedure: Percutaneous coronary intervention (PCI) Implantation of coronary stent Other Names: PCI PTCA

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Planned implantation of drug eluting stent
Written informed consent

Exclusion Criteria:

Planned intervention with other stents than study stents

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00388934

Sponsors and Collaborators

Skejby Hospital

University of Aarhus

University of Copenhagen

Odense University Hospital

Investigators

Principal Investigator:

Anders Galloe, MD

Gentofte Hospital, Copenhagen

More Information

No publications provided by Skejby Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Department of Cardiology B, Aarhus University Hospital Skejby
ClinicalTrials.gov Identifier:	NCT00388934 History of Changes
Other Study ID Numbers:	SORT-OUT II
Study First Received:	October 16, 2006
Last Updated:	March 26, 2010
Health Authority:	Denmark: National Board of Health

Keywords provided by Skejby Hospital:

Percutaneous coronary intervention
Angina pectoris
Stent

Additional relevant MeSH terms:

Angina Pectoris
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases

Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on February 12, 2012