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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: January 2, 2012
Last Update Posted: October 14, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hospices Civils de Lyon
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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]

Secondary Outcome Measures:
  • Ejection fraction [ Time Frame: at 1 year ]
    Functional outcome

  • Left-Ventricular End-Diastolic Volume (LVEDV) [ Time Frame: at 1 year ]
    Functional outcome

  • Left-Ventricular End-Systolic Volume (LVESV) [ Time Frame: at 1 year ]
    Functional outcome

  • Total mortality [ Time Frame: at 1 year ]
  • Cardiovascular death [ Time Frame: at 1 year ]
  • Heart failure [ 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

  • Myocardial infarction [ Time Frame: at 1 year ]
  • Unstable angina [ Time Frame: at 1 year ]
  • Stroke [ Time Frame: at 1 year ]
  • Infarct size [ 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

  • Infarct size: peak Troponin (T or I) [ Time Frame: At admission and at 4 hours (+/- 30 minutes) after study treatment administration ]
    Explorative outcome. Cardiac prognostic factors.

  • Microvascular obstruction (no reflow) [ Time Frame: During hospitalization at admission ]
    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


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01502774

  Show 45 Study Locations
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 ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01502774     History of Changes
Other Study ID Numbers: 2009.559
First Submitted: December 28, 2011
First Posted: January 2, 2012
Last Update Posted: October 14, 2016
Last Verified: October 2016

Keywords provided by Hospices Civils de Lyon:
reperfusion injury

Additional relevant MeSH terms:
Myocardial Infarction
ST Elevation Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
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