Butylphthalide for Brain Edema After Endovascular Treatment (NCT07528456) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Butylphthalide for Brain Edema After Endovascular Treatment
China100 participantsStarted 2026-04-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥18 years.
✓. Time from onset to randomization within 24 hours.
✓. Confirmed occlusion of the internal carotid artery or the M1 segment of the middle cerebral artery by digital subtraction angiography (DSA).
✓. 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.
✓. Received endovascular treatment with successful reperfusion (mTICI ≥2b).
✓. Signed informed consent form by the subject or their legally authorized representative.
✕. History or evidence of intracerebral hemorrhage, subarachnoid hemorrhage, arteriovenous malformation, cerebral aneurysm, or brain tumor.
✕. Evidence (clinical or radiological) of concurrent infarction in the contralateral cerebral hemisphere that, in the investigator's judgment, may affect functional prognosis.
✕
What they're measuring
1
Delta cerebrospinal fluid
Timeframe: 72hours after the stroke onset
Trial details
NCT IDNCT07528456
SponsorNanfang Hospital, Southern Medical University
. Clinical or radiological evidence of vertebral or basilar artery occlusion.
✕. 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.
✕. Use of butylphthalide within 7 days prior to enrollment.