drugset / Trial / NCT00426049

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

NCT00426049

Phase 3 Unknown 484 enrolled German Heart Institute Novartis · collab
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2006-10
Primary completion
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Everolimus Small molecule Oral

Indications