Edaravone-Sodium Ozagrel Comparative Post-Marketing Study on Acute Ischemic Stroke

Completed

Phase 4 Results

Trial Description

This study is randomized, Sodium Ozagrel (Thromboxane A2 Synthase Inhibitor) controlled study on acute ischemic stroke. The primary endpoints were the rate of patients with modified Rankin Scale score of 0-1 at 3 months.

Conditions

Interventions

  • Edaravone (3-methyl-1-phenyl-2-pyrazolin-5-one)Drug
    Other Names: Radicut
    Intervention Desc: Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
    ARM 1: Kind: Experimental
    Label: 1
    ARM 2: Kind: Experimental
    Label: Edaravone
  • Sodium Ozagrel Drug
    Intervention Desc: Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
    ARM 1: Kind: Experimental
    Label: 2
    ARM 2: Kind: Experimental
    Label: Ozagrel

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary the rate of patients with a modified Rankin Scale score of 0-1 3 months No
Secondary Barthel Index score 3 months No
Secondary NIH Stroke Scale score 14 days, 1 month and 3 months No
Secondary Japan Stroke Scale (Motor Function) score 14 days, 1 month and 3 months No
Secondary modified Rankin Scale score 6 months No
Secondary Safety 3 months Yes
Secondary Baseline NIH Stroke Scale Score Before treatment initiation No
Secondary NIH Stroke Scale Score at 14 Days 14 days No
Secondary NIH Stroke Scale Score at 1 Month 1 month No
Secondary NIH Stroke Scale Score at 3 Months 3 months No
Secondary Japan Stroke Scale (Motor Function) Score at 14 Days 14 days No
Secondary Japan Stroke Scale (Motor Function) Score at 1 Month 1 month No
Secondary Japan Stroke Scale (Motor Function) Score at 3 Months 3 months No

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