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

NCT ID: NCT02934217

Last Updated: 2018-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 868 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2017-06-28

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.

Conditions

ST Elevation Acute Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Cyclosporin

one single intravenous bolus injection of 2.5 mg/Kg Echocardiography

Group Type: EXPERIMENTAL

Injection of Cyclosporin

Intervention Type: DRUG

one single intravenous bolus injection of 2.5 mg/Kg

Echocardiography

Intervention Type: PROCEDURE

3 years after AMI

Control

one single intravenous bolus injection of Placebo Echocardiography

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

One single intravenous bolus injection of Placebo

Echocardiography

Intervention Type: PROCEDURE

3 years after AMI

Interventions

Injection of Cyclosporin

one single intravenous bolus injection of 2.5 mg/Kg

Intervention Type: DRUG

Placebo

One single intravenous bolus injection of Placebo

Intervention Type: DRUG

Echocardiography

3 years after AMI

Intervention Type: PROCEDURE

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).

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michel OVIZE, Prof

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

Hôpital Louis Pradel

Bron, , France

Countries

France

Other Identifiers

2013-830

Identifier Type: -

Identifier Source: org_study_id