A Phase 3 interventional study of Injection of Cyclosporin and Placebo in ST Elevation Acute Myocardial Infarction, sponsored by Hospices Civils de Lyon. Completed at 45 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-04.
Sponsored by Hospices Civils de Lyon · Phase 3, Interventional, and Treatment
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.
667 studies on the registry are indexed under ST Elevation Myocardial Infarction; 180 are open to participants now.
This study's enrollment of 970 is above the median of 194 across 427 interventional studies indexed under ST Elevation Myocardial Infarction.
Browse ST Elevation Myocardial Infarction studies →Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Eligibility criteria (for screening before hospital admission):
For whom the clinical decision was made to treat with percutaneous coronary intervention (PCI).
And (further inclusion criteria to be confirmed by the admission coronary-angiography):
Patients undergoing either primary PCI or rescue PCI are eligible for the study. Patients with previous AMI, PCI or coronary artery bypass surgery (CABG) are eligible for the study.
Exclusion Criteria:
Injection of Cyclosporin A : one single intravenous bolus injection of 2.5 mg/Kg Echocardiography
Drug: Injection of Cyclosporin · Procedure: Echocardiography
one single intravenous bolus injection of Placebo Echocardiography
Drug: Placebo · Procedure: Echocardiography
one single intravenous bolus injection of 2.5 mg/Kg
Also known as: Cyclosporin A (CicloMulsion, verum)
One single intravenous bolus injection of Placebo
1 year after AMI
Combined incidence of [total mortality; hospitalization for heart failure; LV remodeling (increase of LV end-diastolic volume > 15%)]
Time frame: at 1 year post-AMI
Ejection fraction
Functional outcome
Time frame: at 1 year
Left-Ventricular End-Diastolic Volume (LVEDV)
Functional outcome
Time frame: at 1 year
Left-Ventricular End-Systolic Volume (LVESV)
Functional outcome
Time frame: at 1 year
Total mortality
Time frame: at 1 year
Cardiovascular death
Time frame: at 1 year
Heart failure
In-hospital worsening of heart failure after reperfusion, or rehospitalization for: a)worsening of a heart failure existing at admission, b)appearance of "new" heart failure
Time frame: at 1 year
Myocardial infarction
Time frame: at 1 year
Unstable angina
Time frame: at 1 year
Stroke
Time frame: at 1 year
Infarct size
Measured by cardiac MRI, only for patients included in participating centers where cardiac MRI is part of the usual post-infarct care
Time frame: at 1 year
Infarct size: peak Troponin (T or I)
Explorative outcome. Cardiac prognostic factors.
Time frame: At admission and at 4 hours (+/- 30 minutes) after study treatment administration
Microvascular obstruction (no reflow)
Explorative outcome. Cardiac prognostic factors.
Time frame: During hospitalization at admission
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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ST Elevation Myocardial Infarction→
Hospices Civils de Lyon