Pilot Study of Edaravone to Treat Acute Myocardial Infarction

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-04-30

Study Completion Date

2007-06-30

Brief Summary

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Early reperfusion therapy has improved the clinical outcomes of patients with acute myocardial infarction (AMI), but these benefits are limited in some patients by reperfusion injuries. There is now increasing evidence that reactive oxygen species cause reperfusion injury. This study was designed to examine the effects of edaravone, a novel free radical scavenger, in patients with AMI.

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Detailed Description

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Initial AMI patients were randomly assigned to receive 30 mg of edaravone or a placebo intravenously just before reperfusion. We compared infarct size, using serial determination of serum biomarkers and Q wave formations, and the incidence of reperfusion arrhythmia between the groups. Cardiovascular event-free curves were estimated by Kaplan-Meier method. In addition, we determined serum thioredoxin levels, an oxidative stress marker, to assess the antioxidant effect of edaravone.

Conditions

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Myocardial Infarction Reperfusion Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Edaravone Group

Group Type ACTIVE_COMPARATOR

edaravone

Intervention Type DRUG

intravenous administration of 30mg Edaravone just before reperfusion therapy

2

Placebo Group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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edaravone

intravenous administration of 30mg Edaravone just before reperfusion therapy

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Initial AMI patients admitted to the investigators' institution within 6 hours of symptom onset and treated primary percutaneous coronary intervention.

Exclusion Criteria

* Renal insufficiency defined as serum creatinine \> 1.2 mg/dl and altered hepatic function defined as serum asparate aminotransferase \> 50 IU/L, alanine aminotransferase \> 50 IU/L and total bilirubin \> 1.2 mg/dl.

Eligible Sex

ALL

Accepts Healthy Volunteers

No