Infarct size is a major determinant of vital prognosis after AMI. We recently reported that cyclosporine A, when administered immediately prior to PCI reperfusion, can significantly reduce infarct size in STEMI patients. The CIRCUS study aimed at determining the impact of cyclosporine on the combined incidence of (death, hospitalization for heart failure, LV remodelling) at one year after AMI. However, many patients may display increased adverse LV remodelling beyond year 1 and develop heart failure thereafter. The present CIRCUS II trial aims at examining the 3-year clinical outcome of all patients recruited in the CIRCUS study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
868
one single intravenous bolus injection of 2.5 mg/Kg
One single intravenous bolus injection of Placebo
3 years after AMI
Hôpital Louis Pradel
Bron, France
Combined incidence of [total mortality; hospitalization for heart failure; LV remodeling (increase of LV end-diastolic volume > 15%)]
Time frame: at 12 months post-AMI.
Time to first event [total mortality, hospitalization for heart failure]
Functional outcome
Time frame: until 3 years post-AMI
Total mortality
Time frame: at 12 months post-AMI.
Total mortality
Time frame: at 3 years post-AMI.
Cardiovascular death
Time frame: at 3 years post-AMI.
Cardiovascular death
Time frame: at 12 months post-AMI.
Heart failure
Time frame: at 12 months post-AMI.
Heart failure
Time frame: at 3 years post-AMI.
Myocardial infarction
Time frame: at 12 months post-AMI.
Myocardial infarction
Time frame: at 3 years post-AMI.
Unstable angina
Time frame: at 12 months post-AMI.
Unstable angina
Time frame: at 3 years post-AMI.
Stroke
Time frame: at 12 months post-AMI.
Stroke
Time frame: at 3 years post-AMI.
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 12 months post-AMI.
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 3 years post-AMI.
Quality of life
Assessed by the EQ-5D-3L
Time frame: at 3 years post-AMI.
Adverse events
Time frame: at 3 years post-AMI.
Ejection fraction
Time frame: at 12 months post-AMI
Left-ventricular End-Diastolic Volume (LVEDV)
Time frame: at 12 months post-AMI
Left-ventricular End-Systolic Volume (LVESV)
Time frame: at 12 months post-AMI
Infarct size: peak Troponin (T or I)
Time frame: at 4 hours (+/- 30 minutes) after study treatment administration
Microvascular obstruction
assessed by Magnetic resonance imaging
Time frame: at 48 hours post-AMI
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