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

Phase 3

Completed

• Conditions: ST Elevation Acute Myocardial Infarction
• Interventions: Drug: Injection of Cyclosporin; Drug: Placebo; Procedure: Echocardiography

• Registration Number: NCT02934217
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2016-10-13
• Study First Submitted QC: 2016-10-13
• Study First Posted: 2016-10-14
• Primary Completion: 2017-06-28
• Study Completion: 2017-06-28
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-17
• Last Update Posted: 2018-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 868

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cyclosporin	Injection of Cyclosporin	one single intravenous bolus injection of 2.5 mg/Kg Echocardiography
Cyclosporin	Echocardiography	one single intravenous bolus injection of 2.5 mg/Kg Echocardiography
Control	Placebo	one single intravenous bolus injection of Placebo Echocardiography
Control	Echocardiography	one single intravenous bolus injection of Placebo Echocardiography

Primary Outcome Measures

Name	Time	Method
Combined incidence of [total mortality; hospitalization for heart failure; LV remodeling (increase of LV end-diastolic volume > 15%)]	at 12 months post-AMI.

Secondary Outcome Measures

Name	Time	Method
Heart failure	at 3 years post-AMI.
Left-ventricular End-Systolic Volume (LVESV)	at 12 months post-AMI
Infarct size: peak Troponin (T or I)	at 4 hours (+/- 30 minutes) after study treatment administration
Cardiovascular death	at 12 months post-AMI.
Microvascular obstruction	at 48 hours post-AMI	assessed by Magnetic resonance imaging
Time to first event [total mortality, hospitalization for heart failure]	until 3 years post-AMI	Functional outcome
Total mortality	at 3 years post-AMI.
Ejection fraction	at 12 months post-AMI
Left-ventricular End-Diastolic Volume (LVEDV)	at 12 months post-AMI
Myocardial infarction	at 3 years post-AMI.
Unstable angina	at 3 years post-AMI.
Stroke	at 3 years post-AMI.
Infarct size	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
Quality of life	at 3 years post-AMI.	Assessed by the EQ-5D-3L
Adverse events	at 3 years post-AMI.

Trial Locations

Locations (1)

Hôpital Louis Pradel; 🇫🇷 Bron, France