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| Name | Class |
|---|---|
| Japan Heart Foundation | OTHER |
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Edaravone Group |
|
| 2 | No Intervention | Placebo Group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| edaravone | Drug | intravenous administration of 30mg Edaravone just before reperfusion therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac Death | number of cardiac death | 415±32 days |
| Nonfatal Myocardial Reinfarction | number of nonfatal myocardial reinfarction | 415days |
| Refractory Angina Pectoris | number of refractory angina pectoris | 415days |
| Nonfatal Ischemic Stroke | number of nonfatal ischemic stroke | 415days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hisao Ogawa, MD, PhD | Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University | Kumamoto | 860-8556 | Japan |
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| ID | Title | Description |
|---|---|---|
| FG000 | Edaravone Group | Edaravone Group edaravone: intravenous administration of 30mg Edaravone just before reperfusion therapy |
| FG001 | Placebo Group | Placebo Group |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Edaravone Group | Edaravone Group edaravone: intravenous administration of 30mg Edaravone just before reperfusion therapy |
| BG001 | Placebo Group | Placebo Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cardiac Death | number of cardiac death | Posted | Number | events | 415±32 days |
|
|
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adverse events were only collected during the therapy period, up to 2 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Edaravone Group | Edaravone Group edaravone: intravenous administration of 30mg Edaravone just before reperfusion therapy |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kenichi Tsujita | Kumamoto University | +81-96-373-5175 | tsujita@kumamoto-u.ac.jp |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D015427 | Reperfusion Injury |
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000077553 | Edaravone |
| ID | Term |
|---|---|
| D000983 | Antipyrine |
| D047069 | Pyrazolones |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 |
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| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Nonfatal Myocardial Reinfarction | number of nonfatal myocardial reinfarction | Posted | Number | events | 415days |
|
|
|
| Primary | Refractory Angina Pectoris | number of refractory angina pectoris | Posted | Number | events | 415days |
|
|
|
| Primary | Nonfatal Ischemic Stroke | number of nonfatal ischemic stroke | Posted | Number | events | 415days |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | Placebo Group | Placebo Group | 0 | 51 | 0 | 51 |
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| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D011183 | Postoperative Complications |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |