Does Cyclosporine ImpRove Clinical oUtcome in ST Elevation Myocardial Infarction Patients (CIRCUS)

NCT01502774 Phase 3 COMPLETED

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.

Details

Lead sponsor	Hospices Civils de Lyon
Phase	Phase 3
Status	COMPLETED
Enrolment	970
Start date	2011-04
Completion	2015-02

Conditions

• ST Elevation Acute Myocardial Infarction

Interventions

• Injection of Cyclosporin
• Placebo
• Echocardiography

Primary outcomes

• Combined incidence of [total mortality; hospitalization for heart failure; LV remodeling (increase of LV end-diastolic volume > 15%)] — at 1 year post-AMI

Countries

Belgium, France, Spain