NCT03284463

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

Safety and Efficacy of Glibenclamide Combined With Rt-PA in Treating Acute Ischemic Stroke: a Prospective, Randomized, Double-blind, Placebo-control, Multi-center Study

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 306 (actual)
• Sponsor: Nanfang Hospital, Southern Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

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

• Acute Stroke

Interventions

Type	Name	Description
DRUG	Glibenclamide	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.
DRUG	Placebo	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.

Timeline

• Start date: 2018-01-01
• Primary completion: 2022-08-28
• Completion: 2023-05-28
• First posted: 2017-09-15
• Last updated: 2023-06-12

Locations

8 sites across 1 country: China