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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
970
one single intravenous bolus injection of 2.5 mg/Kg
One single intravenous bolus injection of Placebo
1 year after AMI
Algemeen Ziekenhuis Sint-Jan Brugge
Bruges, Belgium
Chu Charleroi
Charleroi, Belgium
Hôpital universitaire d'Anvers (UZA)
Edegem, Belgium
CHU Mont-Godinne
Yvoir, Belgium
Clinique ESQUIROL - SAINT-HILAIRE
Agen, France
Centre Hospitalier du Pays D'Aix
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
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Aix-en-Provence, France
Centre Hospitalier Universitaire d'Angers
Angers, France
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Annecy, France
Hôpital Henri Duffaut
Avignon, France
Clinique Lafourcade
Bayonne, France
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