Acute ischemic stroke
Conditions
Interventions
Experimental group:Sublingual administration of Edaravone and Dexborneol Sublingual Tablets at a dose of 36 mg (containing 30 mg edaravone and 6 mg dexborneol), twice daily, for 7 consecutive days.
Control group:The placebo was administered in the same sublingual manner as the experimental group and contained all components except the active ingredients edaravone and borneol, simulating the cool
Sponsors
The First Affiliated Hospital of Chengdu Medical College
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >=18 years old; 2.Clinically diagnosed with acute cerebral infarction, presenting as anterior circulation large vessel occlusion (LVO), particularly involving the distal internal carotid artery, T-bifurcation, or M1 segment of the middle cerebral artery; 3.Onset time of symptoms: 6–24 hours; 4.Multimodal imaging evaluation meets the criteria for direct endovascular thrombectomy (EVT) or bridging therapy: (1) The latest head CT scan indicates an Alberta Stroke Program Early Computed Tomography Score (ASPECTS) of 6–10 points; (2) Patients with symptom onset of 6–16 hours must meet the mismatch criteria of the DEFUSE-3 trial, including: core infarct volume =1.8, and ischemic penumbra volume > 15 ml; or meet the mismatch criteria of the DAWN trial, including: National Institutes of Health Stroke Scale (NIHSS) score>=10 points with core infarct volume =20 points with core infarct volume <= 51 ml; (3) Patients with symptom onset of 16–24 hours must meet the mismatch criteria of the DAWN trial; 5.Planned to receive bridging therapy (intravenous thrombolysis [IVT] with alteplase or tenecteplase followed by EVT) or direct EVT; 6.Pre-illness modified Rankin Scale (mRS) score <=1; 7.NIHSS score before EVT: 6–25 points; 8.Informed consent obtained (from the patient himself/herself or his/her authorized representative).
Exclusion criteria
Exclusion criteria: 1.Computed tomography (CT) scan reveals intracranial hemorrhagic disorders, such as intracerebral parenchymatous hemorrhage, subarachnoid hemorrhage, intraventricular hemorrhage, subdural hemorrhage, etc; 2.Hypersensitivity to any component of Sublingual edaravone dexborneol; 3.Current receipt of edaravone, edaravone dexborneol, or any medications containing borneol or other cytoprotectants; 4.A history of congenital (e.g., coagulation factor deficiency, thrombocytopenia) or acquired bleeding disorders; 5.Persistent elevation of systolic blood pressure exceeding 180 mm Hg or diastolic blood pressure exceeding 110 mm Hg after treatment; 6.Serum levels of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeding three times the upper limit of normal (ULN); 7.Serum creatinine exceeding 1.5 times the upper limit of normal (ULN), or estimated glomerular filtration rate (eGFR) less than 60 mL/min; 8.Pregnant or lactating women, or women planning to become pregnant within 90 days; 9.Patients unable to complete informed consent and subsequent follow-up due to severe mental disorders or dementia; 10.Patients with malignant tumors, severe systemic diseases, or a life expectancy of less than 90 days; 11.Patients who have participated in other interventional studies within 30 days prior to randomization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in hypoperfusion volume;The proportion of symptomatic intracranial hemorrhage on CT within 24 hours after endovascular treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of Effective Reperfusion;The change in NIHSS score at 7 days after treatment;90-day Modified Rankin Scale score;The change in volume with a 30% reduction in relative cerebral blood flow (rCBF) on computed tomography perfusion (CTP) at 7 days after treatment;All-cause mortality within 90 days;Symptomatic intracranial hemorrhage within 36 hours;Deterioration of neurological deficit;The proportion of adverse events within 90 days; | — |
Countries
China
Contacts
Public ContactYu Jianping
The First Affiliated Hospital of Chengdu Medical College
Outcome results
None listed