NCT06472921

Efficacy and Safety of Early Initiation of Butylphthalide Treatment in Patients With Acute Ischemic Stroke.

Effect of Early Initiation of Butylphthalide on Neural Function in Patients With Acute Ischemic Stroke -A Prospective, Multicenter, Randomized, Open-label, Blinded End Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 204 (actual)
• Sponsor: Xiangya Hospital of Central South University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, multicenter, randomized, open-label, blinded-endpoint trial designed to evaluate the difference in efficacy of Butylphthalide Sodium Chloride Injection treatment initiated early (\<3 hours) versus late (3-6 hours) in patients with acute ischemic stroke. The aim is to determine the optimal timing window for neuroprotective therapy.

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
BEHAVIORAL	Butylphthalide treatment initiation time	Eligible participants with acute ischemic stroke will be randomly assigned in a 1:1 ratio to two groups: an early initiation group (\<3 hours) and a late initiation group (3-6 hours).

Timeline

• Start date: 2024-07-29
• Primary completion: 2025-11-01
• Completion: 2025-11-20
• First posted: 2024-06-25
• Last updated: 2025-11-25

Locations

2 sites across 1 country: China