Randomized Clinical Comparison of the Endeavor and the Cypher Coronary Stents in Non-selected Angina Pectoris Patients

NCT ID: NCT00660478

Last Updated: 2013-08-29

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2342 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2009-10-31

Brief Summary

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Randomized clinical comparison of the serolimus eluting Cypher stent and the zotarolimus eluting Endeavor stent.

Detailed Description

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Conditions

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Ischemic Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Zotarolimus eluting stent

Group Type ACTIVE_COMPARATOR

Endeavor

Intervention Type DEVICE

Comparison of two different drug eluting coronary stents

2

Sirolimus stent

Group Type ACTIVE_COMPARATOR

Cypher Select

Intervention Type DEVICE

Comparison of two different drug eluting coronary stents

Interventions

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Endeavor

Comparison of two different drug eluting coronary stents

Intervention Type DEVICE

Cypher Select

Comparison of two different drug eluting coronary stents

Intervention Type DEVICE

Other Intervention Names

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1. Endeavor 1. Cypher

Eligibility Criteria

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Inclusion Criteria

* All patients treated with one or more drug eluting stents in the coronary arteries at one of the 5 heart centers in Denmark can be included in the study.

Exclusion Criteria

* The patient will not participate
* The patient participates in other randomized stent studies
* Expected survival \< 1 year
* Allergy to Aspirin, Clopidogrel or Ticlopidine
* Allergy to Sirolimus or ABT-578
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aalborg University Hospital

OTHER

Sponsor Role collaborator

Odense University Hospital

OTHER

Sponsor Role collaborator

University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role collaborator

Evald Hoej Christiansen

OTHER

Sponsor Role lead

Responsible Party

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Evald Hoej Christiansen

MD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jens F Lassen, MD, PhD

Role: STUDY_CHAIR

Aarhus University Hospital Skejby

Klaus Rasmussen, MD, DMSc

Role: PRINCIPAL_INVESTIGATOR

Aalborg University Hospital

Locations

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Aarhus University Hospital, Skejby

Aarhus, , Denmark

Site Status

Countries

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Denmark

References

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Maeng M, Tilsted HH, Jensen LO, Krusell LR, Kaltoft A, Kelbaek H, Villadsen AB, Ravkilde J, Hansen KN, Christiansen EH, Aaroe J, Jensen JS, Kristensen SD, Botker HE, Thuesen L, Madsen M, Thayssen P, Sorensen HT, Lassen JF. Differential clinical outcomes after 1 year versus 5 years in a randomised comparison of zotarolimus-eluting and sirolimus-eluting coronary stents (the SORT OUT III study): a multicentre, open-label, randomised superiority trial. Lancet. 2014 Jun 14;383(9934):2047-2056. doi: 10.1016/S0140-6736(14)60405-0. Epub 2014 Mar 14.

Reference Type DERIVED
PMID: 24631162 (View on PubMed)

Maeng M, Tilsted HH, Jensen LO, Kaltoft A, Kelbaek H, Abildgaard U, Villadsen AB, Krusell LR, Ravkilde J, Hansen KN, Christiansen EH, Aaroe J, Jensen JS, Kristensen SD, Botker HE, Madsen M, Thayssen P, Sorensen HT, Thuesen L, Lassen JF. 3-Year clinical outcomes in the randomized SORT OUT III superiority trial comparing zotarolimus- and sirolimus-eluting coronary stents. JACC Cardiovasc Interv. 2012 Aug;5(8):812-8. doi: 10.1016/j.jcin.2012.04.008.

Reference Type DERIVED
PMID: 22917452 (View on PubMed)

Jensen LO, Maeng M, Thayssen P, Villadsen A, Krusell L, Botker HE, Pedersen KE, Aaroe J, Christiansen EH, Vesterlund T, Hansen KN, Ravkilde J, Tilsted HH, Lassen JF, Thuesen L. Late lumen loss and intima hyperplasia after sirolimus-eluting and zotarolimus-eluting stent implantation in diabetic patients: the diabetes and drug-eluting stent (DiabeDES III) angiography and intravascular ultrasound trial. EuroIntervention. 2011 Jul;7(3):323-31. doi: 10.4244/EIJV7I3A56.

Reference Type DERIVED
PMID: 21729834 (View on PubMed)

Rasmussen K, Maeng M, Kaltoft A, Thayssen P, Kelbaek H, Tilsted HH, Abildgaard U, Christiansen EH, Engstrom T, Krusell LR, Ravkilde J, Hansen PR, Hansen KN, Abildstrom SZ, Aaroe J, Jensen JS, Kristensen SD, Botker HE, Madsen M, Johnsen SP, Jensen LO, Sorensen HT, Thuesen L, Lassen JF; SORT OUT III study group. Efficacy and safety of zotarolimus-eluting and sirolimus-eluting coronary stents in routine clinical care (SORT OUT III): a randomised controlled superiority trial. Lancet. 2010 Mar 27;375(9720):1090-9. doi: 10.1016/S0140-6736(10)60208-5. Epub 2010 Mar 16.

Reference Type DERIVED
PMID: 20231034 (View on PubMed)

Other Identifiers

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20050194

Identifier Type: -

Identifier Source: org_study_id