Acute Ischemic Stroke
Conditions
Keywords
Acute Ischemic Stroke, Endovascular therapy, Butylphthalide, Cerebral edema, Prognosis
Brief summary
This is a prospective, multicenter, randomized controlled clinical study aimed at evaluating the efficacy of butylphthalide in improving the severity of cerebral edema and prognosis in patients with acute anterior circulation large vessel occlusion after endovascular treatment.
Interventions
DRUGButylphthalide
For patients in the butylphthalide group, Butylphthalide and Sodium Chloride Injection was administered immediately after randomization, 100 ml per dose, intravenously, twice daily, for at least 7 days, continuing until discharge or day 14.
DRUGPlacebo
For patients in the placebo group, Placebo Injection was administered immediately after randomization, 100 ml per dose, intravenously, twice daily, for at least 7 days, continuing until discharge or day 14.
Sponsors
Nanfang Hospital, Southern Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years. 2. Time from onset to randomization within 24 hours. 3. Confirmed occlusion of the internal carotid artery or the M1 segment of the middle cerebral artery by digital subtraction angiography (DSA). 4. NIHSS score ≥10 at onset, or NIHSS score \>8 at 1 hour post-procedure (for those able to cooperate with NIHSS assessment), or CT-ASPECTS score 3-7 immediately post-procedure. 5. Received endovascular treatment with successful reperfusion (mTICI ≥2b). 6. Signed informed consent form by the subject or their legally authorized representative.
Exclusion criteria
1. Pre-stroke modified Rankin Scale (mRS) score ≥2. 2. Immediate post-procedure CT indicating PH2 hemorrhagic transformation or subarachnoid hemorrhage. 3. Immediate post-procedure CT indicating cerebral herniation or planned decompressive craniectomy. 4. History or evidence of intracerebral hemorrhage, subarachnoid hemorrhage, arteriovenous malformation, cerebral aneurysm, or brain tumor. 5. Evidence (clinical or radiological) of concurrent infarction in the contralateral cerebral hemisphere that, in the investigator's judgment, may affect functional prognosis. 6. Clinical or radiological evidence of vertebral or basilar artery occlusion. 7. History of severe renal impairment (e.g., on dialysis) or estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m²; severe hepatic disease or alanine aminotransferase (ALT) \>3× the upper limit of normal, or total bilirubin \>2× the upper limit of normal. 8. Use of butylphthalide within 7 days prior to enrollment. 9. Known allergy to butylphthalide. 10. Pregnancy. 11. Breastfeeding women who do not agree (or whose legally authorized representative does not allow) to discontinue breastfeeding during the study drug administration period and for 7 days thereafter. 12. Participation in other purely observational stroke studies, or expected survival \<6 months unrelated to the current stroke, or unlikely to comply with follow-up requirements. 13. Currently receiving another investigational drug with the same or similar mechanism of action as the study drug. 14. Any condition that, in the investigator's opinion, makes the subject unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Delta cerebrospinal fluid | 72hours after the stroke onset | Change from baseline in cerebrospinal fluid |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptomatic intracranial hemorrhage | 72hours after the stroke onset | Symptomatic intracranial hemorrhage associated with neurological deterioration (increase in NIHSS ≥4 points) confirmed by CT or MRI. |
| NWU | 72hours after the stroke onset | Net water uptake assessed by CT |
| CED grade | 72hours after the stroke onset | Cerebral edema grade assessed by CT |
| rHV | 72hours after the stroke onset | Relative hemispheric volume ratio assessed by CT |
| Malignant cerebral edema | 48 to 96 hours after onset | Defined as the presence of cerebral edema with mass effect on cranial CT or MRI within 48 to 96 hours after symptom onset, including midline shift ≥ 5 mm and/or compression of ventricles or cisterns. |
| Midline shift distance | 72 to 96 hours after onset | Maximum distance of midline shift (in millimeters) measured on axial CT or MRI. |
| Early neurological deterioration | Within 7 days post-treatment | Defined as an increase of ≥4 points on the National Institutes of Health Stroke Scale (NIHSS; range 0-42, with higher scores indicating worse outcome) within 7 days post-treatment. |
| Decompressive craniectomy | Within 7 days post-treatment | The subject underwent decompressive craniectomy due to clinical necessity. |
| Infarct volume | 48-96hours after the stroke onset | Infarct volume assessed by computed tomography (CT) or magnetic resonance imaging (MR) |
| Modified Rankin Scale of 0 to 2 points | 90 days after the stroke onset | Modified Rankin Scale (mRS; range 0-6, with higher scores indicating worse outcome) score of 0 to 2 points. |
| Distribution of modified Rankin Scale (mRS) scores | 90 days after the stroke onset | Shift analysis of mRS scores at 90 days (range 0-6). |
Countries
China
Contacts
CONTACTKaibin Huang, PhD
CONTACTSuyue Pan, PhD
Outcome results
None listed