Myocardial InfarctionPhase 4NCT00265239
Pilot Study of Edaravone to Treat Acute Myocardial Infarction
A Phase 4 study testing edaravone in people with Myocardial Infarction and Reperfusion Injury, run by Kumamoto University at 1 site in Japan.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Myocardial Infarction, Reperfusion Injury
- What is being tested?
- edaravone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteJapan
- Study dates
- Apr 2001to Jun 2007
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Initial AMI patients admitted to the investigators' institution within 6 hours of symptom onset and treated primary percutaneous coronary intervention.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Japan1 site
Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
Kumamoto, 860-8556
About this study
Official title: Effects of Edaravone in Patients With Acute Myocardial Infarction
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.
Read the 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.
- Conditions
- Myocardial Infarction, Reperfusion Injury
- Being tested
- edaravone
- Keywords
- Edaravone, Randomized Control Trial, ST-Elevation Myocardial Infarction, Coronary Angioplasty
- Medical subject headings
- Myocardial Infarction, Reperfusion Injury, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
edaravoneDrug
intravenous administration of 30mg Edaravone just before reperfusion therapy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Edaravone Group Receives: Drug: edaravone |
| 2 | No intervention | Placebo Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Death
number of cardiac death
Measured: 415±32 days
Nonfatal Myocardial Reinfarction
number of nonfatal myocardial reinfarction
Measured: 415days
Refractory Angina Pectoris
number of refractory angina pectoris
Measured: 415days
Nonfatal Ischemic Stroke
number of nonfatal ischemic stroke
Measured: 415days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2005 (estimated)
- Study startApr 2001
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kumamoto University
- Sponsor type
- University, hospital or other
- Collaborators
- Japan Heart Foundation
- Investigators
- Hisao Ogawa, MD, PhD, Study chair, Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00265239
- Sponsor's protocol ID
- 310
- Status last verified
- Nov 2007
- First submitted
- 13 Dec 2005
- Last updated
- 15 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Edaravone in Patients With Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT00265239
- Acronym / sponsor ID
- 310
- Conditions
- Myocardial Infarction, Reperfusion Injury
- Keywords
- Edaravone, Randomized Control Trial, ST-Elevation Myocardial Infarction, Coronary Angioplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Kumamoto UniversityUniversity, hospital or other
- Collaborators
- Japan Heart Foundation
- Study start
- Apr 2001
- Study completion
- Jun 2007 (actual)
- First posted
- 14 Dec 2005 (estimated)
- Results
- Posted 15 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: edaravoneEdaravone Group |
| 2 | No intervention | –Placebo Group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Initial AMI patients admitted to the investigators' institution within 6 hours of symptom onset and treated primary percutaneous coronary intervention.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| edaravoneintravenous administration of 30mg Edaravone just before reperfusion therapy | Drug | 1 |
Primary outcome
Cardiac Death
Time frame: 415±32 days
number of cardiac death
Nonfatal Myocardial Reinfarction
Time frame: 415days
number of nonfatal myocardial reinfarction
Refractory Angina Pectoris
Time frame: 415days
number of refractory angina pectoris
Nonfatal Ischemic Stroke
Time frame: 415days
number of nonfatal ischemic stroke
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hisao Ogawa, MD, PhD study chair
Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing edaravone in people with Myocardial Infarction and Reperfusion Injury, run by Kumamoto University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac Death (time frame: 415±32 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2014.