Hôpital Louis Pradel
Bron, France
NCT Number: NCT02934217
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Bron, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
One single intravenous bolus injection of Placebo
3 years after AMI
Time frame: at 12 months post-AMI.
Time frame: until 3 years post-AMI
Functional outcome
Time frame: at 12 months post-AMI.
Time frame: at 3 years post-AMI.
Time frame: at 3 years post-AMI.
Time frame: at 12 months post-AMI.
Time frame: at 12 months post-AMI.
Time frame: at 3 years post-AMI.
Time frame: at 12 months post-AMI.
Time frame: at 3 years post-AMI.
Time frame: at 12 months post-AMI.
Time frame: at 3 years post-AMI.
Time frame: at 12 months post-AMI.
Time frame: at 3 years post-AMI.
Time frame: at 12 months post-AMI.
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.
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.
Assessed by the EQ-5D-3L
Time frame: at 3 years post-AMI.
Time frame: at 12 months post-AMI
Time frame: at 12 months post-AMI
Time frame: at 12 months post-AMI
Time frame: at 4 hours (+/- 30 minutes) after study treatment administration
Time frame: at 48 hours post-AMI
assessed by Magnetic resonance imaging
Hospices Civils de Lyon
Other
Acronym: CIRCUS II
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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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