Mildronate for Acute Ischemic Stroke

Completed

Phase 2 Results N/A

Trial Description

Mildronate an inhibitor of carnitine-dependent metabolism, is considered an anti-ischemic drug. This study aims to evaluate the efficacy and safety of mildronate injection in treating acute ischemic stroke.

Detailed Description

A randomized, double-blind, multi-center clinical study was made on mildronate injection for treating acute cerebral infarction. 113 cases in the experimental group were given with mildronate injection, while 114 cases in the active-control group were given with cinepazide maleate injection. In addition, both groups were given aspirin as basic treatments. Modified Rankin Scale (mRS) score at 2 weeks and 3 months, National Institutes of Health Stroke Scale (NIHSS) score and Barthel Index score at 2 weeks after treatment, vital signs and adverse events were evaluated.

Conditions

Interventions

  • Aspirin Drug
    Other Names: Aspirin at bedtime
    ARM 1: Kind: Experimental
    Label: mildronate
    Description: infusion of mildronate
    ARM 2: Kind: Experimental
    Label: cinepazide maleate
    Description: infusion of cinepazide maleate
  • Mildronate injection Drug
    Other Names: infusion of mildronate infusion of mildronate(500mg) once a day and for 14 da
    ARM 1: Kind: Experimental
    Label: mildronate
    Description: infusion of mildronate
  • Cinepazide maleate injection Drug
    Other Names: infusion of plabcebo once a day and for 14 days
    ARM 1: Kind: Experimental
    Label: cinepazide maleate
    Description: infusion of cinepazide maleate

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 modified Rankin scale 3 months No
Secondary NIHSS scores 15 days No
Secondary the Barthel index 15 days No

Sponsors