Phase 4
N=104
Pilot Study of Edaravone to Treat Acute Myocardial Infarction
Myocardial Infarction · Reperfusion Injury
Bottom Line
View on ClinicalTrials.gov: NCT00265239 ↗Enrolled (actual)
104
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcome: Primary: Cardiac Death — 0; 0 events
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- edaravone (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Kumamoto University
- Primary completion
- —
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cardiac Death |
0; 0 | — |
| PRIMARY Nonfatal Myocardial Reinfarction |
0; 2 | — |
| PRIMARY Refractory Angina Pectoris |
1; 5 | — |
| PRIMARY Nonfatal Ischemic Stroke |
0; 1 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00265239). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.