Ciclosporin A and Acute Myocardial Infarction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Brief Summary

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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

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Conditions

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Myocardial Infarction

Keywords

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Ischemia Reperfusion Myocardial infarction ciclosporin A acute myocardial infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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ciclosporine A

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Michel Ovize, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

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Michel Ovize

Lyon, , France

Site Status

Countries

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France

References

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Mewton N, Croisille P, Gahide G, Rioufol G, Bonnefoy E, Sanchez I, Cung TT, Sportouch C, Angoulvant D, Finet G, Andre-Fouet X, Derumeaux G, Piot C, Vernhet H, Revel D, Ovize M. Effect of cyclosporine on left ventricular remodeling after reperfused myocardial infarction. J Am Coll Cardiol. 2010 Mar 23;55(12):1200-1205. doi: 10.1016/j.jacc.2009.10.052.

Reference Type DERIVED

PMID: 20298926 (View on PubMed)

Other Identifiers

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2004.353

Identifier Type: -

Identifier Source: org_study_id