Edaravone Dexborneol Sublingual Tablet for the PSCI in Acute Ischemic Stroke Patients

Exclusion Criteria

• •1. Presence of intracranial hemorrhagic disease confirmed by brain imaging.
• •2. Severe disturbance of consciousness: NIHSS 1a level of consciousness item score \> 1 point.
• •3. Transient ischemic attack (TIA).
• •4. Systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 120 mmHg after blood pressure control.
• •5. Poorly controlled diabetes (fasting blood glucose \>10mmol/L and/or HbA1c\>8%).
• •6. Patients with contraindications to MRI imaging.
• •7. For subjects who are scheduled to undergo EEG examination, Patients with contraindications for EEG examination.
• •8. Presence of cognitive dysfunction prior to stroke assessed by informants, that is, the average score of Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE, 16-item version) during the screening period was ≥ 3.19 and the total score was ≥ 51.
• •9. Patients who have been diagnosed with severe mental disorders prior to stroke.
• •10. Severe limb hemiplegia and aphasia and significantly affect cognitive function assessment.
• •11. Patients have received the cognitive enhancers and other anti-dementia drugs within 1 month before the screening period, including but not limited to cholinesterase inhibitors (donepezil, rivastigmine, galantamine) and non-competitive N-methyl-D-aspartate (NMDA) receptor antagonists (memantine) and other drugs (such as mannitol sodium capsules, Ginkgo Biloba Extract Injection, Compound Ginkgo Biloba Tablets, oxiracetam, aniracetam, piracetam，nicergoline, Lecanemab, Donanemab, Aducanumab, etc. ).
• •12. Have been diagnosed with severe active liver disease, such as acute hepatitis, chronic active hepatitis, cirrhosis, etc.; or ALT or AST \> 2.0 × ULN.
• •13. Has been diagnosed with severe active kidney disease, renal insufficiency; or serum creatinine \> 1.5 × ULN.
• •14. Thrombectomy or interventional therapy has been applied or planned after this episode.
• •15. History of malignancy; except for subjects with non-melanoma skin cancer (NMSC) that has been successfully treated and limited cervical cancer in situ. Subjects with a diagnosis of malignancy after enrollment may continue to participate in the study or not at the discretion of the investigator and at the discretion of the subject;
• •16. Suffering from a severe systemic disease with an expected survival period of \<1 year;
• •17. hypersensitivity to dextran camphene, natural ice chips or edaravone or excipients (mannitol, copovidone, microcrystalline cellulose, cross-linked povidone, silicon dioxide, magnesium stearate);
• •18. pregnancy, lactation, and patients planning pregnancy;
• •19. history of major surgery within 4 weeks prior to enrollment;
• •20. participation in another clinical study within 30 days prior to randomization, or ongoing participation in another clinical study;
• •21. in the opinion of the investigator, not suitable for participation in this clinical study.