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

NCT ID: NCT06472921

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 204 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-29
• Study Completion Date: 2025-11-20

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Butylphthalide treatment initiation time

Intervention Type: 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).

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.

Group Type: OTHER

Butylphthalide treatment initiation time

Intervention Type: 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).

Interventions

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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xiangya Hospital of Central South University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Xiangya Hospital, Central South University

Changsha, Hunan, China

Xiangya Hospital, Central South University

Changsha, , China

Countries

China

Other Identifiers

202405104

Identifier Type: -

Identifier Source: org_study_id