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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT01502774
Study type Interventional
Source Hospices Civils de Lyon
Contact
Status Completed
Phase Phase 3
Start date April 2011
Completion date February 2015

See also
  Status Clinical Trial Phase
Completed NCT02151929 - Bioresorbable Vascular Scaffold in Patients With Myocardial Infarction Phase 4
Completed NCT02404376 - COMBinAtion Therapy in Myocardial Infarction: The COMBAT-MI Trial Phase 3
Completed NCT02934217 - Does Cyclosporine ImpRove Clinical oUtcome in ST Elevation Myocardial Infarction Patients at 3 Years of Follow-up. CIRCUS II Study Phase 3
Terminated NCT00650975 - ThromboAblation in Acute Myocardial Infarction Phase 2/Phase 3
Unknown status NCT01420614 - RadIal Versus Femoral InvEstigation in ST Elevation Acute Coronary Syndrome N/A