Neuroprotective Effects of Endovascular Therapy Combined with Edaravone Dexborneol on Acute Large-Core Ischemic Stroke: Modulation of the NLRP3 Inflammasome Pathway

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2026
INTERVENTION: Trial group:Edaravone‐Docetaxel injection concentrate 37.5mg (Edaravone 30mg + Docetaxel 7.5mg) + 0.9% Sodium Chloride Injection 100ml, twice daily for 10‐14 days, with the first dose of Edaravone‐Docetaxel administered before endovascular treatment and no later than femoral artery puncture;Control group:Placebo + 0.9% Sodium Chloride Injection 100ml, twice daily for 10‐14 days, with the first dose of placebo administered before endovascular treatment and no later than femoral artery puncture; CONDITION: Ischemic cerebrovascular disease PRIMARY OUTCOME: 90‐day mortality;Symptomatic intracranial hemorrhage within 48 hours; SECONDARY OUTCOME: Improvement in modified Rankin Scale score at 90 days;Change in National Institutes of Health Stroke Scale score at postoperative day 7;Change in infarct volume;Malignant cerebral edema within 48 hours;Rate of decompressive craniectomy;Incidence of various infections, including pulmonary and urinary tract infections;Trends in blood inflammatory markers at days 1, 3, and 7 after treatment;Asymptomatic intracranial hemorrhage within 48 hours;Non‐intracranial hemorrhagic complications, including gastrointestinal, urinary, oral‐nasal, and subcutaneous hematoma;Non‐hemorrhagic serious adverse events, including brain herniation, secondary epilepsy, and other organ complications involving heart, liver, and kidney;Procedural and device‐related complications; INCLUSION CRITERIA: 1. Age = 18 years; 2. Preliminary diagnosis of acute ischemic stroke due to occlusion of the anterior circulation large vessels (internal carotid artery, M1 and M2 segments of the middle cerebral artery, and A1 segment of the anterior cerebral artery), based on clinical symptoms and imaging findings (CTA/DSA/MRA); 3. Time from symptom onset to randomization within 12 hours; 4. Alberta Stroke Program Early CT Score (ASPECTS) < 6 on admission; 5. National Institutes of Health Stroke Scale (NIHSS) score = 6; 6. Written informed consent obtained from the patient or legally authorized representative.
Epistemonikos ID: 51c97e92ca082e753dc56f14d233f18c4980374b
First added on: Oct 08, 2026