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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01502774
First received: December 28, 2011
Last updated: April 2, 2014
Last verified: March 2014
  Purpose

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 (or 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: one year post-AMI ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • total mortality [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • cardiovascular death [ Time Frame: at 3 years ] [ Designated as safety issue: No ]
  • heart failure [ Time Frame: 3 years after acute MI ] [ Designated as safety issue: No ]
    in-hospital worsening of heart failure after reperfusion, or re-hospitalization for: 1) worsening of a heart failure existing at admission, 2) appearance of "new" heart failure

  • myocardial infarction [ Time Frame: 3 years after acute MI ] [ Designated as safety issue: No ]
  • unstable angina [ Time Frame: 3 years after acute MI ] [ Designated as safety issue: No ]
  • stroke [ Time Frame: 3 years after acute MI ] [ Designated as safety issue: No ]
  • LV remodeling [ Time Frame: 3 years after acute MI ] [ Designated as safety issue: No ]
  • Tolerance to medicinal investigational products [ Time Frame: 3 years after acute MI ] [ Designated as safety issue: Yes ]
    Adverse events


Estimated Enrollment: 972
Study Start Date: April 2011
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cyclosporin
Injection of Cyclosporin : 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 (verum)
Procedure: Echocardiography
2 days, 1 year and 3 years after AMI
Placebo Comparator: Control
one single intravenous bolus injection of Placebo Echocardiography
Drug: Placebo
One single intravenous bolus injection of Placebo
Procedure: Echocardiography
2 days, 1 year and 3 years after AMI

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients aged over 18, having a health coverage, without any legal protection measure
  • 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).
  • The culprit coronary artery has to be the LAD and has to be occluded (TIMI flow grade 0-1) at the time of admission coronary angiography.
  • Patients undergoing either primary PCI or rescue PCI 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;
  • Patients with known hypersensitivity to cyclosporine or to egg, peanut or Soya-bean proteins,
  • known renal insufficiency (either known creatinin clearance < 30 ml/min/1.73m² or current medical care for severe renal insufficiency),
  • known liver insufficiency,
  • 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 or with an active treatment that might modify blood concentration of Cyclosporine (diltiazem, vérapamil…);
  • Female patients currently pregnant or women of childbearing age who were not using contraception;
  • Patients with any disorder associated with immunological dysfunction more recently than 6 months prior to presentation: cancer, lymphoma, known positive serology for HIV, or hepatitis.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01502774

Locations
France
Hopital Louis Pradel
Bron cedex, France, 69677
Sponsors and Collaborators
Hospices Civils de Lyon
  More Information

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01502774     History of Changes
Other Study ID Numbers: 2009.559
Study First Received: December 28, 2011
Last Updated: April 2, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Cyclosporins
Cyclosporine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on April 17, 2014