This trial is active, not recruiting.

Condition st elevation acute myocardial infarction
Treatments injection of cyclosporin, placebo, echocardiography
Phase phase 3
Sponsor Hospices Civils de Lyon
Start date March 2014
End date March 2017
Trial size 868 participants
Trial identifier NCT02934217, 2013-830


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
one single intravenous bolus injection of 2.5 mg/Kg Echocardiography
injection of cyclosporin
one single intravenous bolus injection of 2.5 mg/Kg
3 years after AMI
(Placebo Comparator)
one single intravenous bolus injection of Placebo Echocardiography
One single intravenous bolus injection of Placebo
3 years after AMI

Primary Outcomes

survival free of [all-cause mortality, rehospitalisation for heart failure, re-infarction, unstable angina, stroke]
time frame: at 3 years post-AMI.

Secondary Outcomes

Time to first event [total mortality, hospitalization for heart failure]
time frame: until 3 years post-AMI
Total mortality
time frame: at 3 years post-AMI.
Cardiovascular death
time frame: at 3 years post-AMI.
Heart failure
time frame: at 3 years post-AMI.
Myocardial infarction
time frame: at 3 years post-AMI.
Unstable angina
time frame: at 3 years post-AMI.
time frame: at 3 years post-AMI.
Infarct size
time frame: at 3 years post-AMI.
Quality of life
time frame: at 3 years post-AMI.
Adverse events
time frame: at 3 years post-AMI.

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - All (male and female) patients, aged over 18, without any legal protection measure, - Having a health coverage, - Presenting within 12 hours of the onset of chest pain, - Who have ST segment elevation ≥0.2 mV in two contiguous leads, - 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): - The culprit coronary artery has to be the LAD - The LAD artery has to be occluded (TIMI flow grade 0-1) at the time of admission coronary angiography. - Preliminary oral informed consent followed by signed informed consent as soon as possible. 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: - Patients with loss of consciousness or confused - Patients with cardiogenic shock - Patients with the left circumflex or the right coronary artery (RCA) as the culprit artery, or with evidence of coronary collaterals to the risk region - Patients with an opened (TIMI > 1) LAD coronary artery at admission on initial (admission) coronary angiography - Patients with 5.2. known hypersensitivity to cyclosporine 5.3. known hypersensitivity to egg, peanut or Soya-bean proteins 5.4. known renal insufficiency (either known creatinin clearance < 30 ml/min/1.73m² or current medical care for severe renal insufficiency) 5.5. known liver insufficiency 5.6. uncontrolled (treated or untreated) hypertension (> 180/110 mmHg) - Patients treated with any compound containing Hypericum perforatum (St.-John's-worth) or Stiripentol or Aliskiren or Bosentan or Rosuvastatine - Female patients currently pregnant or women of childbearing age who were not using contraception (oral diagnosis). - Patients with any disorder associated with immunological dysfunction more recently than 6 months prior to presentation 8.2. cancer, lymphoma 8.3. known positive serology for HIV, or hepatitis

Additional Information

Official title Does Cyclosporine ImpRove Clinical oUtcome in ST Elevation Myocardial Infarction Patients at 3 Years of Follow-up. CIRCUS II Study
Principal investigator Michel OVIZE, Prof
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Hospices Civils de Lyon.