Ciclosporin A and Acute Myocardial Infarction

Phase 2

• Conditions: Myocardial Infarction

• Registration Number: NCT00403728
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Beyond its immunosuppressive properties, ciclosporine A (CsA) can also inhibit the opening of a mitochondrial mega-channel called the permeability transition pore (mPTP). Opening of the mPTP plays a key role in cardiomyocyte death during reperfusion following a prolonged ischemic insult. Ciclosporin A has been shown to reduce infarct size when administered at reperfusion in experimental models. The objective of the present study is to determine whether administration of CsA at reperfusion in patients with ongoing acute myocardial infarction treated by coronary angioplasty might reduce infarct size.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2006-11-24
• Study First Submitted QC: 2006-11-24
• Study First Posted: 2006-11-27
• Status Verified: 2007-04
• Last Update Submitted: 2007-04-26
• Last Update Posted: 2007-04-27

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Male and female patients, aged more than 18, with suspected first acute myocardial infarction
• Within 12 hours of the onset of chest pain
• With a need for emergency revascularization by angioplasty. Patients must display a fully occluded (TIMI zero flow) culprit coronary artery, absence of visible collaterals and exhibit TIMI flow >2 after direct stenting by angioplasty.

Exclusion Criteria

• Hypersensibility to ciclosporine A
• Cardiac arrest or cardiogenic shock
• Immunosuppressive disease (< 6 months): cancers, lymphomas, positive serology for HIV, hepatitis, etc.
• Known renal failure or serum creatinine > 120 µmole/l at admission
• Liver failure
• Uncontrolled hypertension
• Current pregnancy or women without contraception

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Infarct size evaluated primarily by the area under the curve of CK and troponin I release over the first 72 hours of reperfusion.

Secondary Outcome Measures

Name	Time	Method
Myocardial contractile reserve assessed by dobutamine echocardiography at day 5.
No reflow evaluated by MRI at day 5
Recovery of myocardial contraction assessed by echocardiography and MRI at month 3

Trial Locations

Locations (1)

Michel Ovize; 🇫🇷 Lyon, France