Clinical trial NCT02934217: Does Cyclosporine ImpRove Clinical oUtcome in ST Elevation Myocardial Infarction Patients at 3 Years of Follow-up. CIRCUS II Study
Official title: Does Cyclosporine ImpRove Clinical oUtcome in ST Elevation Myocardial Infarction Patients at 3 Years of Follow-up. CIRCUS II Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: ST Elevation Acute Myocardial Infarction
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-10-14
Enrollment: 868
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Combined incidence of [total mortality; hospitalization for heart failure; LV remodeling (increase of LV end-diastolic volume > 15%)]
timeFrame: at 12 months post-AMI.
Secondary outcomes:
measure: Time to first event [total mortality, hospitalization for heart failure]
timeFrame: until 3 years post-AMI
measure: Total mortality
timeFrame: at 12 months post-AMI.
measure: Total mortality
timeFrame: at 3 years post-AMI.
measure: Cardiovascular death
timeFrame: at 3 years post-AMI.
measure: Cardiovascular death
timeFrame: at 12 months post-AMI.
measure: Heart failure
timeFrame: at 12 months post-AMI.
measure: Heart failure
timeFrame: at 3 years post-AMI.
measure: Myocardial infarction
timeFrame: at 12 months post-AMI.
measure: Myocardial infarction
timeFrame: at 3 years post-AMI.
measure: Unstable angina
timeFrame: at 12 months post-AMI.
measure: Unstable angina
timeFrame: at 3 years post-AMI.
measure: Stroke
timeFrame: at 12 months post-AMI.
measure: Stroke
timeFrame: at 3 years post-AMI.
measure: Infarct size
timeFrame: at 12 months post-AMI.
measure: Infarct size
timeFrame: at 3 years post-AMI.
measure: Quality of life
timeFrame: at 3 years post-AMI.
measure: Adverse events
timeFrame: at 3 years post-AMI.
measure: Ejection fraction
timeFrame: at 12 months post-AMI
measure: Left-ventricular End-Diastolic Volume (LVEDV)
timeFrame: at 12 months post-AMI
measure: Left-ventricular End-Systolic Volume (LVESV)
timeFrame: at 12 months post-AMI
measure: Infarct size: peak Troponin (T or I)
timeFrame: at 4 hours (+/- 30 minutes) after study treatment administration
measure: Microvascular obstruction
timeFrame: at 48 hours post-AMI
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Louis Pradel
Study officials:
affiliation: Hospices Civils de Lyon
name: Michel OVIZE, Prof
role: PRINCIPAL_INVESTIGATOR
References: