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

Sponsored by:	Deutsches Herzzentrum Muenchen
Information provided by:	Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:	NCT00598533

Purpose

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

Condition	Intervention	Phase
Coronary Heart Disease	Device: rapamycin+probucol-eluting stent (ISAR stent) Device: polymer based Zotarolimus-eluting stent (Endeavor Resolute)	Phase IV

MedlinePlus related topics: Coronary Artery Disease Heart Diseases

Drug Information available for: Sirolimus Probucol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Prospective, Randomized Trial of Rapamycin- and Zotarolimus-Eluting Stents for the Reduction of Coronary Restenosis

Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	3000
Study Start Date:	February 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator rapamycin+probucol-eluting stent	Device: rapamycin+probucol-eluting stent (ISAR stent) due to randomization, rapamycin- + Probucol-eluting stent will be implanted
2: Active Comparator polymer based Zotarolimus-eluting stent	Device: polymer based Zotarolimus-eluting stent (Endeavor Resolute) due to randomization, Zotarolimus-eluting stent with polymer will be implanted

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. Clinical follow-up will be performed at 30 days and one year.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00598533

Contacts

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

Locations

Germany
Deutsches Herzzentrum Muenchen	Recruiting
Munich, Germany, 80636
Contact: Adnan Kastrati, MD +49 89 1218-0 ext 4577 kastrati@dhm.mhn.de
Principal Investigator: Julinda Mehilli, MD
Medizinische Klinik, Klinikum rechts der Isar	Recruiting
Muenchen, Germany, 81675
Contact: Josef Dirschinger, MD +49 89 4140 2947
Principal Investigator: Josef Dirschinger, MD

Sponsors and Collaborators

Deutsches Herzzentrum Muenchen

Investigators

Study Chair:

Albert Schoemig, MD

Deutsches Herzzentrum Muenchen

More Information

Responsible Party:	Deutsches Herzzentrum Munich ( Prof. A. Schömig )
Study ID Numbers:	GE IDE No. S02907
Study First Received:	January 10, 2008
Last Updated:	March 13, 2008
ClinicalTrials.gov Identifier:	NCT00598533
Health Authority:	Germany: German Institute of Medical Documentation and Information

Study placed in the following topic categories:

Arterial Occlusive Diseases
Sirolimus
Heart Diseases
Probucol
Clotrimazole
Miconazole
Myocardial Ischemia
Tioconazole

Vascular Diseases
Constriction, Pathologic
Ischemia
Arteriosclerosis
Coronary Restenosis
Coronary Stenosis
Coronary Disease
Coronary Artery Disease

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antioxidants
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antilipemic Agents
Physiological Effects of Drugs
Anticholesteremic Agents

Antibiotics, Antineoplastic
Immunosuppressive Agents
Protective Agents
Pharmacologic Actions
Anti-Bacterial Agents
Therapeutic Uses
Antifungal Agents
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009