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Cyclosporine and Prognosis in Acute Myocardial Infarction (MI) Patients (CIRCUS)

This study has been completed.
Information provided by (Responsible Party):
Hospices Civils de Lyon Identifier:
First received: December 28, 2011
Last updated: October 13, 2016
Last verified: October 2016
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.

Condition Intervention Phase
ST Elevation Acute Myocardial Infarction
Drug: Injection of Cyclosporin
Drug: Placebo
Procedure: Echocardiography
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Cyclosporine ImpRove Clinical oUtcome in ST Elevation Myocardial Infarction Patients

Resource links provided by NLM:

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ejection fraction [ Time Frame: at 1 year ] [ Designated as safety issue: No ]
    Functional outcome

  • Left-Ventricular End-Diastolic Volume (LVEDV) [ Time Frame: at 1 year ] [ Designated as safety issue: No ]
    Functional outcome

  • Left-Ventricular End-Systolic Volume (LVESV) [ Time Frame: at 1 year ] [ Designated as safety issue: No ]
    Functional outcome

  • Total mortality [ Time Frame: at 1 year ] [ Designated as safety issue: No ]
  • Cardiovascular death [ Time Frame: at 1 year ] [ Designated as safety issue: No ]
  • Heart failure [ Time Frame: at 1 year ] [ Designated as safety issue: No ]
    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

  • Myocardial infarction [ Time Frame: at 1 year ] [ Designated as safety issue: No ]
  • Unstable angina [ Time Frame: at 1 year ] [ Designated as safety issue: No ]
  • Stroke [ Time Frame: at 1 year ] [ Designated as safety issue: No ]
  • Infarct size [ Time Frame: at 1 year ] [ Designated as safety issue: No ]
    Measured by cardiac MRI, only for patients included in participating centers where cardiac MRI is part of the usual post-infarct care

  • Infarct size: peak Troponin (T or I) [ Time Frame: At admission and at 4 hours (+/- 30 minutes) after study treatment administration ] [ Designated as safety issue: No ]
    Explorative outcome. Cardiac prognostic factors.

  • Microvascular obstruction (no reflow) [ Time Frame: During hospitalization at admission ] [ Designated as safety issue: No ]
    Explorative outcome. Cardiac prognostic factors.

Enrollment: 970
Study Start Date: April 2011
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cyclosporin
Injection of Cyclosporin A : one single intravenous bolus injection of 2.5 mg/Kg Echocardiography
Drug: Injection of Cyclosporin
one single intravenous bolus injection of 2.5 mg/Kg
Other Name: Cyclosporin A (CicloMulsion, verum)
Procedure: Echocardiography
1 year after AMI
Placebo Comparator: Control
one single intravenous bolus injection of Placebo Echocardiography
Drug: Placebo
One single intravenous bolus injection of Placebo
Procedure: Echocardiography
1 year after AMI


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Eligibility criteria (for screening before hospital admission):

  1. All (male and female) patients, aged over 18, without any legal protection measure,
  2. Having a health coverage,
  3. Presenting within 12 hours of the onset of chest pain,
  4. Who have ST segment elevation ≥0.2 mV in two contiguous leads,
  5. 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):

  6. The culprit coronary artery has to be the LAD
  7. The LAD artery has to be occluded (TIMI flow grade 0-1) at the time of admission coronary angiography.
  8. 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:

  1. Patients with loss of consciousness or confused
  2. Patients with cardiogenic shock
  3. 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
  4. Patients with an opened (TIMI > 1) LAD coronary artery at admission on initial (admission) coronary angiography
  5. 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)
  6. Patients treated with any compound containing Hypericum perforatum (St.-John's-worth) or Stiripentol or Aliskiren or Bosentan or Rosuvastatine
  7. Female patients currently pregnant or women of childbearing age who were not using contraception (oral diagnosis).
  8. 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01502774

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Sponsors and Collaborators
Hospices Civils de Lyon
Principal Investigator: Michel OVIZE, MD, Prof Hospices Civils de Lyon
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hospices Civils de Lyon Identifier: NCT01502774     History of Changes
Other Study ID Numbers: 2009.559 
Study First Received: December 28, 2011
Last Updated: October 13, 2016
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hospices Civils de Lyon:
reperfusion injury

Additional relevant MeSH terms:
Myocardial Ischemia
Myocardial Infarction
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors processed this record on October 25, 2016