Comparison of Cypher Select and Taxus Express Coronary Stents
NCT ID: NCT00388934
Last Updated: 2013-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
2095 participants
INTERVENTIONAL
2004-08-31
2009-01-31
Brief Summary
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Detailed Description
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* 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
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Drug eluting stent (Cypher)
Percutaneous coronary intervention with implantation of drug eluting coronary stent (Cypher)
Drug eluting stent
percutaneous intervention with implantation of drug eluting coronary stent
Drug eluting stent (Taxus)
Percutaneous coronary intervention with implantation of drug eluting coronary stent (Taxus)
Drug eluting stent
percutaneous intervention with implantation of drug eluting coronary stent
Interventions
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Drug eluting stent
percutaneous intervention with implantation of drug eluting coronary stent
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Written informed consent
Exclusion Criteria
18 Years
ALL
No
Sponsors
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University of Aarhus
OTHER
University of Copenhagen
OTHER
Odense University Hospital
OTHER
Aarhus University Hospital Skejby
OTHER
Responsible Party
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Aarhus University Hospital Skejby
Principal Investigators
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Anders Galloe, MD
Role: PRINCIPAL_INVESTIGATOR
Gentofte Hospital, Copenhagen
References
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Galloe AM, Kelbaek H, Thuesen L, Hansen HS, Ravkilde J, Hansen PR, Christiansen EH, Abildgaard U, Stephansen G, Lassen JF, Engstrom T, Jensen JS, Jeppesen JL, Bligaard N; SORT OUT II Investigators. 10-Year Clinical Outcome After Randomization to Treatment by Sirolimus- or Paclitaxel-Eluting Coronary Stents. J Am Coll Cardiol. 2017 Feb 14;69(6):616-624. doi: 10.1016/j.jacc.2016.11.055.
Galloe AM, Thuesen L, Kelbaek H, Thayssen P, Rasmussen K, Hansen PR, Bligaard N, Saunamaki K, Junker A, Aaroe J, Abildgaard U, Ravkilde J, Engstrom T, Jensen JS, Andersen HR, Botker HE, Galatius S, Kristensen SD, Madsen JK, Krusell LR, Abildstrom 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. doi: 10.1001/jama.299.4.409.
Other Identifiers
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SORT-OUT II
Identifier Type: -
Identifier Source: org_study_id
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