Edaravone and Argatroban Stroke Therapy Study for Acute Ischemic Stroke "EAST"

Completed

Phase 4 Results

Trial Description

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.

Conditions

Interventions

  • 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

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

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.

Outcomes

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

Sponsors