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.
- Edaravone (3-methyl-1-phenyl-2-pyrazolin-5-one)Drug
Other Names: Radicut Intervention Desc: 30mg/20mL vial, twice per day, not longer than two weeks ARM 1: Kind: Experimental Label: A Description: The patients who are allocated to Argatroban monotherapy ARM 2: Kind: Experimental Label: B Description: The patients who are allocated to Edaravone-Argatroban combination therapy
- Allocation: Randomized
- Masking: Open Label
- Purpose: Treatment
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
Modified Rankin Scale (MRS) score ,NIHSS score, JSS score, Barthel Index, modified Rankin Scale score will be done at baseline and at 3 month follow-up visit and at various other times when indicated by condition. The patients will be randomized to either Argatroban monotherapy or Edaravone-Argatroban combination therapy not longer than two weeks.
|Type||Measure||Time Frame||Safety Issue|
|Primary||Modified Rankin Scale (MRS) score at 3 months, symptomatic intracranial hemorrhage at 3 weeks.|
|Secondary||NIHSS score, JSS score, Barthel Index, modified Rankin Scale score at 3 weeks and again at 3 months; various adverse effects at 3 months.|
|Primary||Modified Rankin Scale (MRS) score||at 3 months||Yes|
|Primary||Symptomatic intracranial hemorrhage||for the initial 3 weeks||Yes|
|Secondary||NIHSS score, JSS score, Barthel Index, modified Rankin Scale score||at various time-points||Yes|
|Secondary||Various adverse effects||for the 3 months||Yes|