Clinical trial NCT00388934: Comparison of Cypher Select and Taxus Express Coronary Stents
Official title: Randomized Clinical Comparison of Cypher Select and Taxus Express Stent Implantation in Unselected Patients With Coronary Artery Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Angina Pectoris
Keywords: Percutaneous coronary intervention
Angina pectoris
Stent
Lead sponsor: Aarhus University Hospital Skejby
Sponsor class: OTHER
Collaborators: name: University of Aarhus
name: University of Copenhagen
name: Odense University Hospital
First posted: 2006-10-17
Enrollment: 2095
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria:

* Planned implantation of drug eluting stent
* Written informed consent

Exclusion Criteria:

* Planned intervention with other stents than study stents

Primary outcomes:
measure: MACE (cardiac death, myocardial infarction, target vessel revascularisation, target lesion revascularisation, TVF)
timeFrame: during 9 months
Secondary outcomes:
measure: Total death
timeFrame: after 9 months, 2 and 3 years
measure: Cardiac death
timeFrame: after 9 months, 2 and 3 years
measure: Myocardial infarction
timeFrame: after 9 months, 2 and 3 years
measure: Target vessel revascularisation, target lesion revascularisation, TVF
timeFrame: after 9 months, 2 and 3 years
measure: Stent thrombosis
timeFrame: after 9 months, 2 and 3 years
Other outcomes:
Locations:
Study officials:
affiliation: Gentofte Hospital, Copenhagen
name: Anders Galloe, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.