Ciclosporin A and Acute Myocardial Infarction

Myocardial Infarction Clinical Trial

Official title:

Protection by Ciclosporine A During Reperfused Acute Myocardial Infarction.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00403728
• Other study ID #: 2004.353
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: November 24, 2006
• Last updated: April 26, 2007
• Start date: September 2004

Study information

• Verified date: April 2007
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Drug:
• ciclosporine A

Locations

Country	Name	City	State
France	Michel Ovize	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infarct size evaluated primarily by the area under the curve of CK and troponin I release over the first 72 hours of reperfusion.
Secondary	Myocardial contractile reserve assessed by dobutamine echocardiography at day 5.
Secondary	No reflow evaluated by MRI at day 5
Secondary	Recovery of myocardial contraction assessed by echocardiography and MRI at month 3