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

NCT06472921 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2025-11-25

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • Xiangya Hospital of Central South University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-29
Primary Completion
2025-11-01
Completion
2025-11-20

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06472921 on ClinicalTrials.gov