This trial is active, not recruiting.

Condition myocardial infarction
Treatment ciclosporine a
Phase phase 2/phase 3
Sponsor Hospices Civils de Lyon
Start date September 2004
Trial size 60 participants
Trial identifier NCT00403728, 2004.353


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind
Primary purpose treatment

Primary Outcomes

Infarct size evaluated primarily by the area under the curve of CK and troponin I release over the first 72 hours of reperfusion.
time frame:

Secondary Outcomes

Myocardial contractile reserve assessed by dobutamine echocardiography at day 5.
time frame:
No reflow evaluated by MRI at day 5
time frame:
Recovery of myocardial contraction assessed by echocardiography and MRI at month 3
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 90 years old.

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

Additional Information

Official title Protection by Ciclosporine A During Reperfused Acute Myocardial Infarction.
Principal investigator Michel Ovize, MD
Trial information was received from ClinicalTrials.gov and was last updated in April 2007.
Information provided to ClinicalTrials.gov by Hospices Civils de Lyon.