NCT01502774

Cyclosporine and Prognosis in Acute Myocardial Infarction (MI) Patients

Does Cyclosporine ImpRove Clinical oUtcome in ST Elevation Myocardial Infarction Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 970 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• ST Elevation Acute Myocardial Infarction

Interventions

Type	Name	Description
DRUG	Injection of Cyclosporin	one single intravenous bolus injection of 2.5 mg/Kg
DRUG	Placebo	One single intravenous bolus injection of Placebo
PROCEDURE	Echocardiography	1 year after AMI

Timeline

• Start date: 2011-04-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2012-01-02
• Last updated: 2025-09-04

Locations

45 sites across 3 countries: Belgium, France, Spain