Overview

Systemic Treatment With Everolimus for the Prevention of MACE After Bare Metal Stent Implantation

Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
German Heart Institute
Collaborator:
Novartis
Treatments:
Everolimus
Sirolimus