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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00426049
Other study ID # CRAD001ADE07
Secondary ID
Status Recruiting
Phase Phase 3
First received January 23, 2007
Last updated January 23, 2007
Start date October 2006

Study information

Verified date January 2007
Source German Heart Institute
Contact Eckart Fleck, Professor
Phone +49-(0)30-4593
Email fleck@dhzb.de
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

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.


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Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Intervention

Drug:
Everolimus


Locations

Country Name City State
Germany German Heart Institute Berlin Berlin

Sponsors (2)

Lead Sponsor Collaborator
German Heart Institute Novartis

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Major adverse cardiac events (MACEs)within 6 months
Secondary MACEs within 30 days
Secondary Quantitative angiographic observations within the vessel after 6 months
Secondary TLR and TVR after 6 months
Secondary Drug safety and tolerability for 6 months
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