Safety and Efficacy of Glibenclamide Combined With Rt-PA in Acute Cerebral Embolism "SE-GRACE"

Not yet recruiting

Phase 4 Results N/A

Trial Description

This study is designed to evaluate the safety and efficacy of oral glibenclamide in acute ischemic stroke patients who under intravenous rt-PA thrombolysis.

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: Placebo is administered with a loading dose of 1.25 mg within 10 hours of stroke onset, orally or through gastric tube, followed by 0.625 mg every 8 hour for 5 days.
    ARM 1: Kind: Experimental
    Label: Placebo
    Description: Placebo for Glibenclamide
  • Glibenclamide Drug
    Intervention Desc: Glibenclamide is administered with a loading dose of 1.25 mg within 10 hours of stroke onset, orally or through gastric tube, followed by 0.625 mg every 8 hour for 5 days.
    ARM 1: Kind: Experimental
    Label: Glibenclamide
    Description: Glibenclamide Tablets

Outcomes

Type Measure Time Frame Safety Issue
Primary Functional outcome: The proportion of mordified Rankin Scale of 0 to 2 points 90 days after the stroke onset
Secondary Early improvement: The proportion of NIHSS decreased ≥ 4 points 7 days after the stroke onset
Secondary Hemorrhagic transformation: The proportion of parenchymal hemorrhagic transformation in cranial CT 96 hours after the stroke onset
Secondary Midline shift: The proportion of midline shift ≥ 6 mm in cranial CT 96 hours after the stroke onset
Secondary Functional outcome 2: The modified Rankin Scale distribution 90 days after the stroke onset
Secondary Functional outcome 3: The proportion of Barthel Index of 95-100 points 90 days after the stroke onset
Secondary Blood-brain barrier: The serum concentration of MMP-9 Baseline, 24, 48, and 72 hours after the stroke onset

Sponsors