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Sponsors and Collaborators: |
German Heart Institute Novartis |
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Information provided by: | German Heart Institute |
ClinicalTrials.gov Identifier: | NCT00426049 |
The purpose of the present study is to provide the first in-human safety and efficacy evaluations of systemic oral anti-proliferative Everolimus therapy compared to placebo in patients treated by bare metal stents for significant coronary artery disease. The aim is to reduce Major Adverse Cardiac Events (MACEs) including death, coronary artery bypass grafting (CABG) to the target vessel, Q-wave and non-Q-wave myocardial infarction, and target lesion revascularization within the first 6 months after intervention. Additionally safety and tolerability of Everolimus at the selected dose in this patient population will be analyzed.
Condition | Intervention | Phase |
---|---|---|
Coronary Artery Disease Coronary Restenosis |
Drug: Everolimus |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Monocenter, Double Blinded, Prospective, Randomized Placebo Controlled Study Investigating Prevention of Major Adverse Cardiac Events (MACEs) Within 6 Months by Systemic Treatment With Everolimus After Coronary Intervention With Bare Metal Stents in Patients With Significant Coronary Artery Disease |
Estimated Enrollment: | 484 |
Study Start Date: | October 2006 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Tandem lesion may be included as long as:
Exclusion Criteria:
The following exclusion criteria must not be present at Baseline visit 1 (BL1, Screening visit prior to coronary intervention). If an exclusion criterion occurred afterwards, e.g., during the coronary intervention, the patient must be excluded from the study.
Target lesion has one or more of the following criteria:
Other protocol defined inclusion/exclusion criteria may apply.
Contact: Eckart Fleck, Professor | +49-(0)30-4593 ext 2400 | fleck@dhzb.de |
Germany | |
German Heart Institute Berlin | Recruiting |
Berlin, Germany, 13353 | |
Principal Investigator: Eckart Fleck, Professor |
Principal Investigator: | Eckart Fleck, Professor | German Heart Institute Berlin |
Study ID Numbers: | CRAD001ADE07 |
Study First Received: | January 23, 2007 |
Last Updated: | January 23, 2007 |
ClinicalTrials.gov Identifier: | NCT00426049 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Coronary artery disease Stents Immunosuppressive Agents Coronary restenosis Safety |
Everolimus Arterial Occlusive Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases |
Constriction, Pathologic Arteriosclerosis Ischemia Coronary Stenosis Coronary Restenosis Coronary Artery Disease |
Immunologic Factors Physiological Effects of Drugs Cardiovascular Diseases Immunosuppressive Agents Pharmacologic Actions |