Clinical trial NCT06472921: Efficacy and Safety of Early Initiation of Butylphthalide Treatment in Patients With Acute Ischemic Stroke.
Official title: Effect of Early Initiation of Butylphthalide on Neural Function in Patients With Acute Ischemic Stroke -A Prospective, Multicenter, Randomized, Open-label, Blinded End Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Acute Ischemic Stroke
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2024-06-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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 (\&lt;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.


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 \&gt;3 times the upper limit of normal or AST levels \&gt;3 times the upper limit of normal; severe renal dysfunction defined as serum creatinine \&gt;3.0 mg/dl \[265.2 μmol/L\] or glomerular filtration rate \[GFR\] \&lt;30 ml/min/1.73m²);
3. Systolic blood pressure \&lt;90 mmHg or \&gt;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.

Primary outcomes:
measure: The proportion of participants with an mRS score of 0-2
timeFrame: 90±7 days post-randomization
Secondary outcomes:
measure: Proportion of participants with an mRS score of 0-1
timeFrame: 90±7 days post-randomization
measure: Changes in NIHSS scores
timeFrame: at 6±1 days and 12±2 days compared to baseline
measure: Proportion of participants with an improvement of ≥4 points in NIHSS scores
timeFrame: at 6±1 days and 12±2 days
measure: Early neurological deterioration
timeFrame: at 24±2 hours and 6±1 days post-randomization
measure: Proportion of participants with ineffective recanalization
timeFrame: at 90±7 days post-randomization
measure: Proportion of participants with recurrent ischemic stroke
timeFrame: at 90±7 days post-randomization
measure: Proportion of combined vascular events (recurrent stroke, myocardial infarction, and vascular death)
timeFrame: at 90±7 days post-randomization
measure: Difference in cerebral infarction volume size
timeFrame: between baseline and 12±2 days post-randomization
measure: Quality of life (EQ-5D) scores
timeFrame: at 90±7 days post-randomization
Other outcomes:
Locations:
Study officials:
References: