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NCT Number: NCT01502774

Cyclosporine and Prognosis in Acute Myocardial Infarction (MI) Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Algemeen Ziekenhuis Sint-Jan Brugge, Bruges, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Eligibility criteria (for screening before hospital admission):

  • 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

Treatment and study plan

Injection of Cyclosporin

Drug

one single intravenous bolus injection of 2.5 mg/Kg

Other names: Cyclosporin A (CicloMulsion, verum)

Placebo

Drug

One single intravenous bolus injection of Placebo

Echocardiography

Procedure

1 year after AMI

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Does Cyclosporine ImpRove Clinical oUtcome in ST Elevation Myocardial Infarction Patients

Acronym: CIRCUS

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jan 2, 2012
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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