Assessment of Revascularization Versus Conservative Treatment in Heart Transplant Patients for a Clinical Event Reduction
Status:
Terminated
Trial end date:
2015-02-01
Target enrollment:
Participant gender:
Summary
The aim of the study is to compare optimal medical therapy alone versus percutaneous coronary
intervention on top of medical therapy in the setting of heart transplant recipient coronary
artery disease in a randomized trial.The primary endpoint assessed at 1 year is the composite
of death, myocardial infarction, need for transitory or permanent ventricular assist device
implantation, myocardial revascularization, occurrence or worsening of heart failure, any
graft dysfunction and/or a decrease of left ventricular ejection fraction of at least 25%
compared to baseline. The hypothesis of the study is the superiority of the interventional
management over medical therapy alone in preventing the occurrence of the primary endpoint of
the study.