Cyclosporine and Prognosis in Acute Myocardial Infarction (MI) Patients
Status:
Completed
Trial end date:
2015-02-01
Target enrollment:
Participant gender:
Summary
Infarct size is a major determinant of prognosis after Acute Myocardial Infarction (AMI). The
investigators recently reported that cyclosporine A, when administered immediately prior to
percutaneous coronary intervention (PCI), can significantly reduce infarct size in STEMI (ST
Elevation acute Myocardial Infarction) patients. The objective of the present study is to
determine whether cyclosporine can improve STEMI patient clinical outcome. Nine-hundred and
seventy two patients with ST elevation MI will be entered into a multicentre, randomized,
placebo-controlled, double-blinded study. They will receive one single injection of
cyclosporine A (CicloMulsion, verum) or an equivalent volume of placebo prior to reperfusion
therapy by PCI. The incidence of the combined endpoint (mortality, hospitalization for heart
failure, left ventricular (LV) remodeling) will be assessed at one year and three years after
treatment.