Myocardial Infarction, Reperfusion Injury
Conditions
Keywords
Edaravone, Randomized Control Trial, ST-Elevation Myocardial Infarction, Coronary Angioplasty
Brief 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.
Detailed 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.
Interventions
DRUGedaravone
intravenous administration of 30mg Edaravone just before reperfusion therapy
Sponsors
Japan Heart Foundation
Kumamoto University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac Death | 415±32 days | number of cardiac death |
| Nonfatal Myocardial Reinfarction | 415days | number of nonfatal myocardial reinfarction |
| Refractory Angina Pectoris | 415days | number of refractory angina pectoris |
| Nonfatal Ischemic Stroke | 415days | number of nonfatal ischemic stroke |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Edaravone Group Edaravone Group
edaravone: intravenous administration of 30mg Edaravone just before reperfusion therapy | 50 |
| Placebo Group Placebo Group | 51 |
| Total | 101 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 |
Baseline characteristics
| Characteristic | Edaravone Group | Placebo Group | Total |
|---|---|---|---|
| Age, Continuous | 63 years STANDARD_DEVIATION 2 | 63 years STANDARD_DEVIATION 2 | 63 years STANDARD_DEVIATION 2 |
| Region of Enrollment Japan | 50 participants | 51 participants | 101 participants |
| Sex: Female, Male Female | 10 Participants | 16 Participants | 26 Participants |
| Sex: Female, Male Male | 40 Participants | 35 Participants | 75 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 50 | 0 / 51 |
| serious Total, serious adverse events | 0 / 50 | 0 / 51 |
Outcome results
Primary
Cardiac Death
number of cardiac death
Time frame: 415±32 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Edaravone Group | Cardiac Death | 0 events |
| Placebo Group | Cardiac Death | 0 events |
Primary
Nonfatal Ischemic Stroke
number of nonfatal ischemic stroke
Time frame: 415days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Edaravone Group | Nonfatal Ischemic Stroke | 0 events |
| Placebo Group | Nonfatal Ischemic Stroke | 1 events |
Primary
Nonfatal Myocardial Reinfarction
number of nonfatal myocardial reinfarction
Time frame: 415days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Edaravone Group | Nonfatal Myocardial Reinfarction | 0 events |
| Placebo Group | Nonfatal Myocardial Reinfarction | 2 events |
Primary
Refractory Angina Pectoris
number of refractory angina pectoris
Time frame: 415days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Edaravone Group | Refractory Angina Pectoris | 1 events |
| Placebo Group | Refractory Angina Pectoris | 5 events |