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

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ClinicalTrials.gov Identifier: NCT01502774
Recruitment Status : Completed
First Posted : January 2, 2012
Last Update Posted : February 26, 2018
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:
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 or disease Intervention/treatment Phase
ST Elevation Acute Myocardial Infarction Drug: Injection of Cyclosporin Drug: Placebo Procedure: Echocardiography Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 970 participants
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
Study Start Date : April 2011
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 :
  1. Ejection fraction [ Time Frame: at 1 year ]
    Functional outcome

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

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

  4. Total mortality [ Time Frame: at 1 year ]
  5. Cardiovascular death [ Time Frame: at 1 year ]
  6. 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

  7. Myocardial infarction [ Time Frame: at 1 year ]
  8. Unstable angina [ Time Frame: at 1 year ]
  9. Stroke [ Time Frame: at 1 year ]
  10. 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

  11. 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.

  12. Microvascular obstruction (no reflow) [ Time Frame: During hospitalization at admission ]
    Explorative outcome. Cardiac prognostic factors.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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
Investigators
Principal Investigator: Michel OVIZE, MD, Prof Hospices Civils de Lyon

Publications:
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 Posted: January 2, 2012    Key Record Dates
Last Update Posted: February 26, 2018
Last Verified: February 2018

Keywords provided by Hospices Civils de Lyon:
STEMI
cyclosporine
reperfusion injury

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
ST Elevation Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Cyclosporins
Cyclosporine
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