Edaravone and Argatroban Stroke Therapy Study for Acute Ischemic Stroke

Study Overview
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Brief Summary
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Edaravone, a free radical scavenger, is a novel neuroprotective agent, and argatroban is a selective thrombin inhibitor. Both the drugs were approved by the Japanese Government, and have frequently been used for the treatment of acute brain infarction in Japan. The effect of combination therapy of these drugs, however, has not yet been elucidated. This study will test the safety and efficacy of the combination therapy with these agents in patients with acute non-cardioembolic and non-lacunar ischemic stroke.

Official Title
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Multicenter Randomized Open-Label Comparison Study on the Efficacy and Safety of Argatroban Monotherapy With Argatroban-Edaravone Combination Therapy

Conditions
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Stroke

Intervention / Treatment
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* Drug: Edaravone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute ischemic stroke < 24 hours of onset Measurable neurological deficits caused by the present attack, ranging from 1 to 22 of NIHSS score on admission Exclusion Criteria: Definite or possible cardiogenic brain infarction Definite lacunar infarction Prior ischemic stroke within 6 months Evidence of hemorrhagic brain infarction, epidural hematoma, intracerebral hematoma, or intraventricular hemorrhage Severe consciousness disturbances (semicoma to deep coma) Neurological signs clearing spontaneously Disability of 2 or more on mRS score before the index stroke aPTT being out of the normal range or 1.5 times longer than the pretreatment value If taking an oral anticoagulant, INR being 1.6 or more, or no INR data Treatment with urokinase, t-PA, heparin, ozagrel sodium, warfarin, or antiplatelet except for aspirin before enrollment Intravascular surgery, surgical operation, hyperbaric oxygen therapy, or hypothermia therapy before enrollment Serum creatinine >1.5 mg/dL Severe hepatic or cardiac disorders, infectious disorders, dehydration, etc. Neoplasm Pregnancy Hypersensitivity to test drugs

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>The patients who are allocated to Argatroban monotherapy | Drug: Edaravone<br>* 30mg/20mL vial, twice per day, not longer than two weeks<br>|
| Active Comparator: B<br>The patients who are allocated to Edaravone-Argatroban combination therapy | Drug: Edaravone<br>* 30mg/20mL vial, twice per day, not longer than two weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Rankin Scale (MRS) score |  | at 3 months | 
| Symptomatic intracranial hemorrhage |  | for the initial 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NIHSS score, JSS score, Barthel Index, modified Rankin Scale score |  | at various time-points | 
| Various adverse effects |  | for the 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Free Radical Scavenger, Selective Thrombin Inhibitor, Acute ischemic stroke (nonlacunar and noncardioembolic)