Injection of Cyclosporin
Drugone single intravenous bolus injection of 2.5 mg/Kg
Other names: Cyclosporin A (CicloMulsion, verum)
NCT Number: NCT01502774
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Algemeen Ziekenhuis Sint-Jan Brugge, Bruges, Belgium
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Eligibility criteria (for screening before hospital admission):
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
one single intravenous bolus injection of 2.5 mg/Kg
Other names: Cyclosporin A (CicloMulsion, verum)
One single intravenous bolus injection of Placebo
1 year after AMI
Time frame: at 1 year post-AMI
Time frame: at 1 year
Functional outcome
Time frame: at 1 year
Functional outcome
Time frame: at 1 year
Functional outcome
Time frame: at 1 year
Time frame: at 1 year
Time frame: at 1 year
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
Time frame: at 1 year
Time frame: at 1 year
Time frame: at 1 year
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 admission and at 4 hours (+/- 30 minutes) after study treatment administration
Explorative outcome. Cardiac prognostic factors.
Time frame: During hospitalization at admission
Explorative outcome. Cardiac prognostic factors.
Hospices Civils de Lyon
Other
Does Cyclosporine ImpRove Clinical oUtcome in ST Elevation Myocardial Infarction Patients
Acronym: CIRCUS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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