Acute Ischemic Stroke (AIS)
Conditions
Interventions
Edaravone Sublingual Tablet:Sublingual Administration
Edaravone Sublingual Blank Tablet:Sublingual Administration
Sponsors
Zhongshan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. 18 Years to 80 Years, including both men and women; 2. There are clear signs of neurological deficit after onset of stroke: 5 <= NIHSS score <= 20; 3. Onset of stroke is less than or equal to 48 hours; 4. Hospitalized patients diagnosed as ischemic stroke according to the diagnostic points of various types of cerebrovascular diseasesof the Fourth National Conference on cerebrovascular diseases, who recovered well after the first or last onset (The mRS score prior to this onset is less than 1) 5. Prior to the start of the trial, Patients or their legal representatives signed written inform consent approved by the ethics committee.
Exclusion criteria
Exclusion criteria: 1. Cranial CT scan finds intracranial bleeding disorders: hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage; 2. Posterior circulation (vertebrobasilar system) infarction; 3. Severe disturbance of consciousness: NIHSS category 1a for consciousness is greater than 1; 4. Transient ischemic attack (TIA); 5. SBP after blood pressure control is still greater than or equal to 220 mmHg, or DBP after blood pressure control is still greater than or equal to 120 mmHg; 6. Patients with severe mental disorders and dementia; 7. ALT or AST is greater than 2.0×ULN or previously known liver diseases, such as acute hepatitis, chronic active hepatitis, liver cirrhosis, etc.; 8. Serum Creatinine (SCr) is greater than 1.5×ULN, Creatinine Clearance (CrCl) is less than 50 mL/min or previously known severe active renal diseasesrenal insufficiency; 9. Therapeutic neuroprotective agents have been applied after onset of stroke, including commercially available edaravone, nimodipine, ganglioside, Cytidine Diphosphate Choline, piracetam, oxiracetam, butyl benzene peptides, urinary kallidinogenase(ureklin), guipizide, rat never growth factor, cerebrolysin (cerebroprotein hydrolysate), bovine serum deproteinized injection, bovine blood deproteinized extract injection, etc. 10. Arterial or venous thrombolytic therapy has been applied after onset of stroke; 11. Patients with malignant tumors or receiving concurrent antitumor treatment; 12. Patients with severe systemic disease, life expectancy is less than 90 days; 13. Allergic to edaravone or related excipients 14. Pregnant or lactating women, also patients planning pregnancy; 15. Have major surgery within 4 weeks before enrollment; 16. Participated in other clinical studies within 30 days before randomization; or participating in other clinical trials at present; 17. The investigators consider the patients are not suitable for this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients with mRS =1 on day 90; | — |
Countries
China
Contacts
Public ContactXin Wang
Zhongshan Hospital Affiliated to Fudan University
Outcome results
None listed