Study of Compound Edaravone Injection for Treatment of Acute Ischemic Stroke

Active, not recruiting

Phase 3 Results N/A

Trial Description

The primary objective of the study is to confirm the efficacy of compound Edaravone Injection via intravenous infusion every 12 hours in the patients with Acute Ischemic Stroke(AIS) in a double-blind, active-controlled manner. The study is also to examine the safety of compound Edaravone Injection for the AIS patients.

Conditions

Interventions

  • Compound Edaravone Injection Drug
    ARM 1: Kind: Experimental
    Label: Compound Edaravone
    Description: Compound Edaravone Injection 37.5mg/dose (Edaravone 30mg, (+)-Borneol 7.5mg), one dose every 12 hours, continue for 14 days
  • Edaravone Injection Drug
    ARM 1: Kind: Experimental
    Label: Edaravone
    Description: Edaravone Injection 30 mg/dose, one dose every 12 hours, continues for 14 days

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary The proportion of patients with mRS ≤1 on day 90 day 90 No
Secondary mRS score on day 90 day 90 No
Secondary Changes of NIHSS score from baseline on day 14 day 14 No
Secondary The proportion of patients with NIHSS score 0-1 (including motor function) on day 14, 30, 90 day 14, 30, 90 No
Secondary The proportion of patients with Barthel Index (BI) score greater than or equal to 95 on day 14, 30, 90 day 14, 30, 90 No
Secondary Montreal Cognitive Assessment(MoCA) score on day 14, 30, 90 day 14, 30, 90 No
Secondary Stroke Impact Scale (SIS) score on day 90 day 90 No

Sponsors