Efficacy and Safety of Mildronate for Acute Ischemic Stroke

Recruiting

Phase 2 Results N/A

Trial Description

This study seeks to evaluate the efficacy and safety of mildronate injection in treating acute ischemic stroke

Detailed Description

a randomized, double-blind, placebo-controlled phase II multicenter trial is conducted to evaluate the efficacy and safety of mildronate injection in patients with acute ischemic stroke. patients will be randomized to receive a 14-day treatment of placebo or mildronate (500mg/5ml/each).Primary end-point is the modified Rankin scale at 3 monthes. Secondary end-point is the NIHSS scores and the Barthel index at 8 days and 15days. The safety end-point is defined as the incidence of adverse events, the change of Samples for routine laboratory tests and vital signs. Analysis is by intention to treat.

Conditions

Interventions

  • Aspirin Drug
    Intervention Desc: infusion of aspirin (100mg) once a day for days
    ARM 1: Kind: Experimental
    Label: mildronate
    Description: infusion of mildronate
    ARM 2: Kind: Experimental
    Label: placebo
    Description: infusion of placebo mildronate
  • Placebo Drug
    Intervention Desc: infusion of plabcebo once a day and for 14 days
    ARM 1: Kind: Experimental
    Label: placebo
    Description: infusion of placebo mildronate
  • Infusion of mildronate Drug
    Intervention Desc: infusion of mildronate(500mg) once a day and for 14 days
    ARM 1: Kind: Experimental
    Label: mildronate
    Description: infusion of mildronate

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 8 days No
Secondary the Barthel index 8 days No

Sponsors