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

NCT06472921 | Completed Phase 2

• 1 other identifier: 202405104
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• The proportion of participants with an mRS score of 0-2

  90±7 days post-randomization

Secondary Outcomes (9)

• Proportion of participants with an mRS score of 0-1

  90±7 days post-randomization

• Changes in NIHSS scores

  at 6±1 days and 12±2 days compared to baseline

• Proportion of participants with an improvement of ≥4 points in NIHSS scores

  at 6±1 days and 12±2 days

• Early neurological deterioration

  at 24±2 hours and 6±1 days post-randomization

• Proportion of participants with ineffective recanalization

  at 90±7 days post-randomization

Study Arms (2)

Early initiation group

EXPERIMENTAL

Treatment with Butylphthalide Sodium Chloride Injection begins within 3 hours, administered at 100ml per dose, infused twice daily for a continuous period of 10-14 days.

Behavioral: Butylphthalide treatment initiation time

Treatment with Butylphthalide Sodium Chloride Injection begins within 3 hours, administered at 100ml

OTHER

Treatment with Butylphthalide Sodium Chloride Injection begins within 3 hours, administered at 100ml per dose, infused twice daily for a continuous period of 10-14 days.

Behavioral: Butylphthalide treatment initiation time

Interventions

Butylphthalide treatment initiation time BEHAVIORAL

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).

Early initiation group; Treatment with Butylphthalide Sodium Chloride Injection begins within 3 hours, administered at 100ml

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 80 years, gender not specified;
• Clinically diagnosed with acute ischemic stroke;
• Stroke onset within 3 hours;
• NIHSS score at enrollment between 4-25 points, with Item Ia ≤1 point;
• Pre-stroke mRS score ≤1 point;
• Participants and their representatives capable and willing to sign an informed consent form.

You may not qualify if:

• Confirmed intracranial hemorrhage within the past 3 months, including intracerebral hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, and subdural/epidural hematoma;
• Known severe hepatic or renal dysfunction or individuals undergoing dialysis for various reasons (severe hepatic dysfunction defined as ALT levels \>3 times the upper limit of normal or AST levels \>3 times the upper limit of normal; severe renal dysfunction defined as serum creatinine \>3.0 mg/dl \[265.2 μmol/L\] or glomerular filtration rate \[GFR\] \<30 ml/min/1.73m²);
• Systolic blood pressure \<90 mmHg or \>220 mmHg;
• Presence of bradycardia (heart rate below 60 beats per minute) or sick sinus syndrome;
• History of drug or food allergies, including known allergies to the components of the study medication;
• Treatment with medications containing Butylphthalide following the onset of the current stroke episode;
• Congenital or acquired hemorrhagic disorders, coagulation factor deficiencies, thrombocytopenia, or similar conditions;
• Pregnant or breastfeeding individuals, or those planning to become pregnant within the next 90 days;
• Severe psychiatric disorders or dementia that preclude understanding of informed consent or compliance with follow-up procedures;
• Concurrent malignancy or severe systemic disease with a life expectancy of less than 90 days;
• Participation in another interventional clinical study within the last 30 days before randomization, or currently participating in another interventional clinical study;
• Any other reason deemed by the investigator as unsuitable for participation in the study.

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead

Study Sites (2)

Xiangya Hospital, Central South University

Changsha, Hunan, 410008, China

Location

Xiangya Hospital, Central South University

Changsha, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Eligible participants with acute ischemic stroke will be randomly assigned in a 1:1 ratio to two groups: an early initiation group and a late initiation group. Early initiation group: Treatment with Butylphthalide Sodium Chloride Injection begins within 3 hours, administered at 100ml per dose, infused twice daily for a continuous period of 10-14 days. Late initiation group: Treatment with Butylphthalide Sodium Chloride Injection begins between 3-6 hours, also administered at 100ml per dose, infused twice daily for a continuous period of 10-14 days.

Study Record Dates

• First Submitted: June 19, 2024
• First Posted: June 25, 2024
• Study Start: July 29, 2024
• Primary Completion: November 1, 2025
• Study Completion: November 20, 2025
• Last Updated: November 25, 2025

Record last verified: 2025-11

Locations

CN (2)