Treatment of Acute Ischemic Stroke With Edaravone Dexborneol Sublingual Tablets in Small Vessel Disease

Inclusion Criteria:

Age: Between 30 and 80 years .

MRI-confirmed recent small subcortical infarct (RSSI): A lesion in the smallpenetrating artery territory, detected as DWI hyperintensity and ADC hypointensity,with a maximum axial diameter ≤20 mm.

White Matter Hyperintensity (WMH) Burden: Fazekas score ≥2 (total score range: 0-6).

Time from Stroke Onset: ≤3 weeks from symptom onset to randomization.

Pre-stroke Functional Status: Modified Rankin Scale (mRS) ≤1 before the indexstroke.

Cognitive Function: No prior diagnosis of cognitive impairment or dementia.

Education Level: At least primary school education and capable of completingcognitive assessments as judged by the investigator.

Contraception Requirements:Women of childbearing potential and male participantswith female partners of childbearing potential must agree to use effectivecontraception during the study and 30 days after the last dose of theinvestigational drug.Female participants must have a negative pregnancy test beforeenrollment.

Informed Consent: Participants or their legal representatives must voluntarily signan informed consent form (ICF).

Exclusion Criteria:

Intracranial Hemorrhagic Diseases: Evidence of hemorrhagic stroke, epiduralhematoma, subarachnoid hemorrhage, or other bleeding disorders detected by headimaging (MRI/CT).However, hemorrhagic transformation may be assessed by theinvestigator for potential inclusion.

Severe Consciousness Disturbance: NIHSS item 1a score >1 (indicative of significantimpairment in consciousness).

Cortical Infarcts or Other Brain Abnormalities:Co-existing cortical infarcts,hydrocephalus, or other non-vascular white matter diseases (e.g., multiplesclerosis, carbon monoxide poisoning-related leukoencephalopathy).

Severe Carotid Artery Stenosis: Requiring surgical intervention (>50% stenosis).

Systemic Conditions Affecting Cognition:Endocrine disorders, vitamin deficiencies,systemic autoimmune diseases that can cause cognitive impairment.

Neurological Disorders Associated with Cognitive Decline:CNS infections,Creutzfeldt-Jakob disease, primary Parkinson's disease, epilepsy, brain tumors, orsevere traumatic brain injury.

Pre-existing Severe Psychiatric Disorders:Diagnosed with major depressive disorder,vascular cognitive impairment, Alzheimer's disease, Parkinson's disease dementia,Lewy body dementia, frontotemporal dementia, or any cognitive dysfunction unrelatedto stroke.

Severe Physical Disability or Language Impairment:Severe hemiplegia or aphasia thatsignificantly affects cognitive assessment.

Use of Cognitive-Enhancing Medications:Within 4 weeks prior to screening, includingbut not limited to:Cholinesterase inhibitors (donepezil, rivastigmine, galantamine),NMDA receptor antagonists (memantine),Other neuroprotective agents (sodiumoligomannate, lecanemab)

Severe Liver or Kidney Dysfunction:Active liver disease (acute hepatitis, chronicactive hepatitis, cirrhosis) or ALT/AST >2× ULN.

Severe renal impairment (serum creatinine >1.5× ULN).

Life Expectancy <1 year due to severe systemic diseases.

Contraindications to MRI:Participants with MRI-incompatible implants, severeclaustrophobia, or inability to undergo MRI.

Known Allergies:History of hypersensitivity to Dexborneol, natural borneol,edaravone, or any excipients (e.g., mannitol, copovidone, microcrystallinecellulose, silica, magnesium stearate).

Pregnancy and Lactation:Pregnant or lactating women, or those planning pregnancyduring the study period.

Participation in Other Clinical Trials:Enrolled in another clinical trial within thelast 30 days.

Other Investigator-Determined Factors:Any other medical, psychological, or socialcondition that, in the investigator's judgment, makes the patient unsuitable forparticipation.