Pilot Study of Edaravone to Treat Acute Myocardial Infarction

Myocardial Infarction Clinical Trial

Official title:

Effects of Edaravone in Patients With Acute Myocardial Infarction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00265239
• Other study ID #: 310
• Status: Completed
• Phase: Phase 4
• First received: December 13, 2005
• Last updated: September 12, 2014
• Start date: April 2001
• Est. completion date: June 2007

Study information

• Verified date: November 2007
• Source: Kumamoto University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Reperfusion Injury

Intervention

Drug:
• edaravone
intravenous administration of 30mg Edaravone just before reperfusion therapy

Locations

Country	Name	City	State
Japan	Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University	Kumamoto

Sponsors (2)

Lead Sponsor	Collaborator
Kumamoto University	Japan Heart Foundation

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac Death	number of cardiac death	415±32 days	No
Primary	Nonfatal Myocardial Reinfarction	number of nonfatal myocardial reinfarction	415days	No
Primary	Refractory Angina Pectoris	number of refractory angina pectoris	415days	No
Primary	Nonfatal Ischemic Stroke	number of nonfatal ischemic stroke	415days	No