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Completed

NCT Number: NCT02934217

Does Cyclosporine ImpRove Clinical oUtcome in ST Elevation Myocardial Infarction Patients at 3 Years of Follow-up. CIRCUS II Study

Infarct size is a major determinant of vital prognosis after AMI. We recently reported that cyclosporine A, when administered immediately prior to PCI reperfusion, can significantly reduce infarct size in STEMI patients. The CIRCUS study aimed at determining the impact of cyclosporine on the combined incidence of (death, hospitalization for heart failure, LV remodelling) at one year after AMI. However, many patients may display increased adverse LV remodelling beyond year 1 and develop heart failure thereafter. The present CIRCUS II trial aims at examining the 3-year clinical outcome of all patients recruited in the CIRCUS study.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hôpital Louis Pradel

Bron, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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 1. known hypersensitivity to cyclosporine 2. known hypersensitivity to egg, peanut or Soya-bean proteins 3. known renal insufficiency (either known creatinin clearance < 30 ml/min/1.73m² or current medical care for severe renal insufficiency) 4. known liver insufficiency 5. 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 1. cancer, lymphoma 2. 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

Placebo

Drug

One single intravenous bolus injection of Placebo

Echocardiography

Procedure

3 years 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 12 months post-AMI.

Secondary outcomes

  1. Time to first event [total mortality, hospitalization for heart failure]

    Time frame: until 3 years post-AMI

    Functional outcome

  2. Total mortality

    Time frame: at 12 months post-AMI.

  3. Total mortality

    Time frame: at 3 years post-AMI.

  4. Cardiovascular death

    Time frame: at 3 years post-AMI.

  5. Cardiovascular death

    Time frame: at 12 months post-AMI.

  6. Heart failure

    Time frame: at 12 months post-AMI.

  7. Heart failure

    Time frame: at 3 years post-AMI.

  8. Myocardial infarction

    Time frame: at 12 months post-AMI.

  9. Myocardial infarction

    Time frame: at 3 years post-AMI.

  10. Unstable angina

    Time frame: at 12 months post-AMI.

  11. Unstable angina

    Time frame: at 3 years post-AMI.

  12. Stroke

    Time frame: at 12 months post-AMI.

  13. Stroke

    Time frame: at 3 years post-AMI.

  14. Infarct size

    Time frame: at 12 months post-AMI.

    Measured by cardiac MRI, only for patients included in participating centers where cardiac MRI is part of the usual post-infarct care

  15. Infarct size

    Time frame: at 3 years post-AMI.

    Measured by cardiac MRI, only for patients included in participating centers where cardiac MRI is part of the usual post-infarct care

  16. Quality of life

    Time frame: at 3 years post-AMI.

    Assessed by the EQ-5D-3L

  17. Adverse events

    Time frame: at 3 years post-AMI.

  18. Ejection fraction

    Time frame: at 12 months post-AMI

  19. Left-ventricular End-Diastolic Volume (LVEDV)

    Time frame: at 12 months post-AMI

  20. Left-ventricular End-Systolic Volume (LVESV)

    Time frame: at 12 months post-AMI

  21. Infarct size: peak Troponin (T or I)

    Time frame: at 4 hours (+/- 30 minutes) after study treatment administration

  22. Microvascular obstruction

    Time frame: at 48 hours post-AMI

    assessed by Magnetic resonance imaging

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: CIRCUS II

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Oct 14, 2016
Registry last updated
May 22, 2018

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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