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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02934217
• Date of registration: 13/10/2016
• Prospective Registration: No
• Primary sponsor: Hospices Civils de Lyon
• Public title: Does Cyclosporine ImpRove Clinical oUtcome in ST Elevation Myocardial Infarction Patients at 3 Years of Follow-up. CIRCUS II Study CIRCUS II
• Scientific title: Does Cyclosporine ImpRove Clinical oUtcome in ST Elevation Myocardial Infarction Patients at 3 Years of Follow-up. CIRCUS II Study
• Date of first enrolment: March 2014
• Target sample size: 868
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02934217
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

France

Contacts

• Name: Michel OVIZE, Prof
• Affiliation: Hospices Civils de Lyon

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

ST Elevation Acute Myocardial Infarction

Intervention(s)

Procedure: Echocardiography

Drug: Injection of Cyclosporin

Drug: Placebo

Primary Outcome(s)

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 Outcome(s)

Cardiovascular death [Time Frame: at 3 years post-AMI.]

Heart failure [Time Frame: at 12 months post-AMI.]

Myocardial infarction [Time Frame: at 12 months post-AMI.]

Myocardial infarction [Time Frame: at 3 years post-AMI.]

Heart failure [Time Frame: at 3 years post-AMI.]

Infarct size [Time Frame: at 12 months post-AMI.]

Infarct size: peak Troponin (T or I) [Time Frame: at 4 hours (+/- 30 minutes) after study treatment administration]

Left-ventricular End-Systolic Volume (LVESV) [Time Frame: at 12 months post-AMI]

Microvascular obstruction [Time Frame: at 48 hours post-AMI]

Stroke [Time Frame: at 12 months post-AMI.]

Adverse events [Time Frame: at 3 years post-AMI.]

Total mortality [Time Frame: at 12 months post-AMI.]

Infarct size [Time Frame: at 3 years post-AMI.]

Left-ventricular End-Diastolic Volume (LVEDV) [Time Frame: at 12 months post-AMI]

Ejection fraction [Time Frame: at 12 months post-AMI]

Unstable angina [Time Frame: at 12 months post-AMI.]

Cardiovascular death [Time Frame: at 12 months post-AMI.]

Quality of life [Time Frame: at 3 years post-AMI.]

Stroke [Time Frame: at 3 years post-AMI.]

Time to first event [total mortality, hospitalization for heart failure] [Time Frame: until 3 years post-AMI]

Total mortality [Time Frame: at 3 years post-AMI.]

Unstable angina [Time Frame: at 3 years post-AMI.]

Secondary ID(s)

2013-830

Source(s) of Monetary Support

Please refer to primary and secondary sponsors