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

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 informedconsent form.

Exclusion Criteria:

1. Confirmed intracranial hemorrhage within the past 3 months, including intracerebralhemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, andsubdural/epidural hematoma;

2. Known severe hepatic or renal dysfunction or individuals undergoing dialysis forvarious reasons (severe hepatic dysfunction defined as ALT levels >3 times theupper limit of normal or AST levels >3 times the upper limit of normal; severerenal dysfunction defined as serum creatinine >3.0 mg/dl [265.2 μmol/L] orglomerular 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 sinussyndrome;

5. History of drug or food allergies, including known allergies to the components ofthe study medication;

6. Treatment with medications containing Butylphthalide following the onset of thecurrent 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 withinthe next 90 days;

9. Severe psychiatric disorders or dementia that preclude understanding of informedconsent 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 daysbefore randomization, or currently participating in another interventional clinicalstudy;

12. Any other reason deemed by the investigator as unsuitable for participation in thestudy.