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

November 20, 2025 updated by: Xiangya Hospital of Central South University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

204

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Changsha, China
        • Xiangya Hospital, Central South University
    • Hunan
      • Changsha, Hunan, China, 410008
        • Xiangya Hospital, Central South University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Confirmed intracranial hemorrhage within the past 3 months, including intracerebral hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, and subdural/epidural hematoma;
  2. 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);
  3. Systolic blood pressure <90 mmHg or >220 mmHg;
  4. Presence of bradycardia (heart rate below 60 beats per minute) or sick sinus syndrome;
  5. History of drug or food allergies, including known allergies to the components of the study medication;
  6. Treatment with medications containing Butylphthalide following the onset of the current stroke episode;
  7. Congenital or acquired hemorrhagic disorders, coagulation factor deficiencies, thrombocytopenia, or similar conditions;
  8. Pregnant or breastfeeding individuals, or those planning to become pregnant within the next 90 days;
  9. Severe psychiatric disorders or dementia that preclude understanding of informed consent or compliance with follow-up procedures;
  10. Concurrent malignancy or severe systemic disease with a life expectancy of less than 90 days;
  11. Participation in another interventional clinical study within the last 30 days before randomization, or currently participating in another interventional clinical study;
  12. Any other reason deemed by the investigator as unsuitable for participation in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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).
Other: Treatment with Butylphthalide Sodium Chloride Injection begins within 3 hours, administered at 100ml
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
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The proportion of participants with an mRS score of 0-2
Time Frame: 90±7 days post-randomization
90±7 days post-randomization

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of participants with an mRS score of 0-1
Time Frame: 90±7 days post-randomization
90±7 days post-randomization
Changes in NIHSS scores
Time Frame: at 6±1 days and 12±2 days compared to baseline
at 6±1 days and 12±2 days compared to baseline
Proportion of participants with an improvement of ≥4 points in NIHSS scores
Time Frame: at 6±1 days and 12±2 days
at 6±1 days and 12±2 days
Early neurological deterioration
Time Frame: at 24±2 hours and 6±1 days post-randomization
at 24±2 hours and 6±1 days post-randomization
Proportion of participants with ineffective recanalization
Time Frame: at 90±7 days post-randomization
at 90±7 days post-randomization
Proportion of participants with recurrent ischemic stroke
Time Frame: at 90±7 days post-randomization
at 90±7 days post-randomization
Proportion of combined vascular events (recurrent stroke, myocardial infarction, and vascular death)
Time Frame: at 90±7 days post-randomization
at 90±7 days post-randomization
Difference in cerebral infarction volume size
Time Frame: between baseline and 12±2 days post-randomization
between baseline and 12±2 days post-randomization
Quality of life (EQ-5D) scores
Time Frame: at 90±7 days post-randomization
at 90±7 days post-randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiangya Hospital of Central South University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 29, 2024

Primary Completion (Actual)

November 1, 2025

Study Completion (Actual)

November 20, 2025

Study Registration Dates

First Submitted

June 19, 2024

First Submitted That Met QC Criteria

June 19, 2024

First Posted (Actual)

June 25, 2024

Study Record Updates

Last Update Posted (Actual)

November 25, 2025

Last Update Submitted That Met QC Criteria

November 20, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202405104

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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