Ciclosporin A and Acute Myocardial Infarction

Civil Hospices of Lyon

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Myocardial Infarction

Treatments: Drug: ciclosporine A

Study type: Interventional

Funder types: Other

Identifiers

NCT00403728

2004.353

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind