Trial Outcomes & Findings for Pilot Study of Edaravone to Treat Acute Myocardial Infarction (NCT NCT00265239)

NCT ID: NCT00265239

Last Updated: 2014-09-15

Results Overview

number of cardiac death

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 104 participants
• Primary outcome timeframe: 415±32 days
• Results posted on: 2014-09-15

Participant Flow

Participant milestones

Measure	Edaravone Group Edaravone Group edaravone: intravenous administration of 30mg Edaravone just before reperfusion therapy	Placebo Group Placebo Group
Overall Study STARTED	52	52
Overall Study COMPLETED	50	51
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Measure	Edaravone Group Edaravone Group edaravone: intravenous administration of 30mg Edaravone just before reperfusion therapy	Placebo Group Placebo Group
Overall Study Adverse Event	2	1

Baseline Characteristics

Pilot Study of Edaravone to Treat Acute Myocardial Infarction

Baseline characteristics by cohort

Measure	Edaravone Group n=50 Participants Edaravone Group edaravone: intravenous administration of 30mg Edaravone just before reperfusion therapy	Placebo Group n=51 Participants Placebo Group	Total n=101 Participants Total of all reporting groups
Age, Continuous	63 years STANDARD_DEVIATION 2 • n=5 Participants	63 years STANDARD_DEVIATION 2 • n=7 Participants	63 years STANDARD_DEVIATION 2 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	16 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants	35 Participants n=7 Participants	75 Participants n=5 Participants
Region of Enrollment Japan	50 participants n=5 Participants	51 participants n=7 Participants	101 participants n=5 Participants

PRIMARY outcome

Timeframe: 415±32 days

number of cardiac death

Outcome measures

Measure	Edaravone Group n=50 Participants Edaravone Group edaravone: intravenous administration of 30mg Edaravone just before reperfusion therapy	Placebo Group n=51 Participants Placebo Group
Cardiac Death	0 events	0 events

PRIMARY outcome

Timeframe: 415days

number of nonfatal myocardial reinfarction

Outcome measures

Measure	Edaravone Group n=50 Participants Edaravone Group edaravone: intravenous administration of 30mg Edaravone just before reperfusion therapy	Placebo Group n=51 Participants Placebo Group
Nonfatal Myocardial Reinfarction	0 events	2 events

PRIMARY outcome

Timeframe: 415days

number of refractory angina pectoris

Outcome measures

Measure	Edaravone Group n=50 Participants Edaravone Group edaravone: intravenous administration of 30mg Edaravone just before reperfusion therapy	Placebo Group n=51 Participants Placebo Group
Refractory Angina Pectoris	1 events	5 events

PRIMARY outcome

Timeframe: 415days

number of nonfatal ischemic stroke

Outcome measures

Measure	Edaravone Group n=50 Participants Edaravone Group edaravone: intravenous administration of 30mg Edaravone just before reperfusion therapy	Placebo Group n=51 Participants Placebo Group
Nonfatal Ischemic Stroke	0 events	1 events

Adverse Events

Edaravone Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Kenichi Tsujita

Kumamoto University

Phone: +81-96-373-5175

Email: tsujita@kumamoto-u.ac.jp

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place