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:
Aarhus University Hospital Skejby
ClinicalTrials.gov Identifier:
NCT00388934
First received: October 16, 2006
Last updated: July 29, 2013
Last verified: May 2007

October 16, 2006
July 29, 2013
August 2004
January 2006   (final data collection date for primary outcome measure)
MACE (cardiac death, myocardial infarction, target vessel revascularisation, target lesion revascularisation, TVF) [ Time Frame: during 9 months ] [ Designated as safety issue: Yes ]
MACE (cardiac death, MI, TVR, TLR, TVF)during 9 months
Complete list of historical versions of study NCT00388934 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Myocardial infarction [ Time Frame: after 9 months, 2 and 3 years ] [ Designated as safety issue: Yes ]
  • Target vessel revascularisation, target lesion revascularisation, 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 ]
  • 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
Not Provided
Not Provided
 
Comparison of Cypher Select and Taxus Express Coronary Stents
Randomized Clinical Comparison of Cypher Select and Taxus Express Stent Implantation in Unselected Patients With Coronary Artery Disease.

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.

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
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Coronary Artery Disease
  • Angina Pectoris
Device: Drug eluting stent
percutaneous intervention with implantation of drug eluting coronary stent
Other Names:
  • DES
  • Cypher
  • Taxus
  • Experimental: Drug eluting stent (Cypher)
    Percutaneous coronary intervention with implantation of drug eluting coronary stent (Cypher)
    Intervention: Device: Drug eluting stent
  • Experimental: Drug eluting stent (Taxus)
    Percutaneous coronary intervention with implantation of drug eluting coronary stent (Taxus)
    Intervention: Device: Drug eluting stent
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.
 
Completed
2095
January 2009
January 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Planned implantation of drug eluting stent
  • Written informed consent

Exclusion Criteria:

  • Planned intervention with other stents than study stents
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00388934
SORT-OUT II
Yes
Department of Cardiology B, Aarhus University Hospital Skejby
Aarhus University Hospital Skejby
  • University of Aarhus
  • University of Copenhagen
  • Odense University Hospital
Principal Investigator: Anders Galloe, MD Gentofte Hospital, Copenhagen
Aarhus University Hospital Skejby
May 2007

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