Efficacy Study of Rapamycin- and Zotarolimus-Eluting Stents to Reduce Coronary Restenosis - Tabular View

Tracking Information

First Received Date ^ICMJE

January 10, 2008

Last Updated Date

January 27, 2009

Start Date ^ICMJE

February 2008

Estimated Primary Completion Date

November 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

A composite endpoint of cardiac death, myocardial infarction related to the target vessel or target lesion revascularisation [ Time Frame: at one year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00598533 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Late luminal loss [ Time Frame: at 6-8 months follow-up angiography ] [ Designated as safety issue: No ]
stent thrombosis [ Time Frame: at one year ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Efficacy Study of Rapamycin- and Zotarolimus-Eluting Stents to Reduce Coronary Restenosis

Official Title ^ICMJE

Prospective, Randomized Trial of Rapamycin- and Zotarolimus-Eluting Stents for the Reduction of Coronary Restenosis

Brief Summary

The purpose of this trial is to evaluate the efficacy of Rapamycin- and Zotarolimus-Eluting stents for the reduction of Coronary Restenosis

Detailed Description

This prospective, randomized trial will compare the efficacy and safety of a Rapamycin plus Probucol-eluting stent with a polymer based Zotarolimus-eluting stent. Patients with symptomatic coronary artery disease without cardiogenic shock who will undergo coronary angiography and willing to participate in the trial will receive a loading dose of 600mg clopidogrel at least 2 hours before the procedure. They will be randomized to receive one of the above mentioned stents.

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Coronary Heart Disease

Intervention ^ICMJE

Device: Rapamycin + Probucol-eluting stent (ISAR stent)
Device: polymer based Zotarolimus-eluting stent (Endeavor Resolute)

Study Arms / Comparison Groups

Active Comparator: Rapamycin + Probucol-eluting stent
Active Comparator: Polymer based Zotarolimus-eluting stent

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

3000

Estimated Completion Date

December 2009

Estimated Primary Completion Date

November 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients older than age 18 with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥ 50% de novo stenosis located in native coronary vessels
Written, informed consent by the patient or her/his legally-authorized representative for participation in the study
In women with childbearing potential a negative pregnancy test is mandatory.

Exclusion Criteria:

Target lesion located in the left main trunk.
Target lesion located in the bypass graft.
In-stent restenosis.
Cardiogenic shock.
Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance.
Known allergy to the study medications: Clopidogrel, Rapamycin, Probucol, Zotarolimus, stainless steel or cobalt chrome.
Inability to take clopidogrel for at least 6 months.
Pregnancy (present, suspected or planned) or positive pregnancy test.
Previous enrollment in this trial.
Patient's inability to fully cooperate with the study protocol.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Adnan Kastrati, MD	+49 89 12 18-0 ext 4577	kastrati@dhm.mhn.de
Contact: Julinda Mehilli, MD	+49 89 12 18-0 ext 4582	mehilli@dhm.mhn.de

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00598533

Responsible Party

Prof. A. Schömig, Deutsches Herzzentrum Munich

Study ID Numbers ^ICMJE

GE IDE No. S02907

Study Sponsor ^ICMJE

Deutsches Herzzentrum Muenchen

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Albert Schoemig, MD

Deutsches Herzzentrum Muenchen

Information Provided By

Deutsches Herzzentrum Muenchen

Verification Date

January 2009

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