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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
484
German Heart Institute Berlin
Berlin, State of Berlin, Germany
RECRUITINGMajor adverse cardiac events (MACEs)within 6 months
MACEs within 30 days
Quantitative angiographic observations within the vessel after 6 months
TLR and TVR after 6 months
Drug safety and tolerability for 6 months
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