Acute Ischemic Stroke
Conditions
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.
Interventions
BEHAVIORALButylphthalide 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
Xiangya Hospital of Central South University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of participants with an mRS score of 0-2 | 90±7 days post-randomization |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Proportion of participants with an mRS score of 0-1 | 90±7 days post-randomization |
| Proportion of combined vascular events (recurrent stroke, myocardial infarction, and vascular death) | at 90±7 days post-randomization |
| Difference in cerebral infarction volume size | between baseline and 12±2 days post-randomization |
| Quality of life (EQ-5D) scores | at 90±7 days post-randomization |
| Proportion of participants with recurrent ischemic stroke | at 90±7 days post-randomization |
Countries
China
Outcome results
None listed