Safety and Efficacy of Edaravone Dexborneol for Acute Ischemic Stroke

Inclusion Criteria:

1. Age ≥ 18 years old and ≤ 80 years old, regardless of gender;

2. Patients diagnosed as acute ischemic stroke according to "key points for diagnosisof all kinds of major cerebrovascular diseases in China 2019", and able to randomiseand initiate edaravone dexborneol treatment less than or equal to 48 hours of strokeonset.

3. Total National Institute of Health stroke scale (NIHSS)≥6 and ≤24, and the sum ofNIHSS score for the upper limb and the lower limb is greater than or equal to 2;

4. modified Rankin Scale (mRS) score of 1 or less before onset.

5. Did not receive edaravone dexborneol treatment before enrollment;

6. The informed consent approved by the ethics committee was voluntarily signed by thepatient or his legal representative.

Exclusion Criteria:

1. Reperfusion therapy (intravenous thrombolysis and endovascular therapy) has beenreceived or planned after stroke onset.

2. Transient ischemic attack (TIA);

3. Posterior circulation stroke;

4. Intracranial hemorrhagic diseases seen in head imaging: hemorrhagic stroke, epiduralhematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoidhemorrhage, etc;

5. Severe disturbance of consciousness: the item score of 1a consciousness level ofNIHSS was more than 1;

6. Patients with severe mental disorders and dementia;

7. Systolic blood pressure after blood pressure control is still higher than 220mmhg ordiastolic blood pressure was higher than 120mmhg;

8. Severe cardiac insufficiency, dissection and acute pericarditis; Severe liverinsufficiency, ALT or AST > 3.0 × ULN; Or severe active liver diseases have beendiagnosed, such as acute hepatitis, chronic active hepatitis, cirrhosis, etc;Severerenal insufficiency, Serum Creatinine (SCr) is greater than 200μmol/L, CreatinineClearance (CrCl) is less than 30 ml/min or receiving hemodialysis; Or suffering fromsevere systemic diseases, the estimated survival time is less than 90 days;

9. Complicated with malignant tumor or undergoing anti-tumor treatment;

10. Therapeutic neuroprotective agents have been applied after onset of stroke,including commercially available edaravone, nimodipine, ganglioside, citicoline,piracetam, butyl benzene peptides, Urinary Kallidinogenase, Ginkgolide.

11. Patients during pregnancy, lactation and planned pregnancy;

12. Allergic to dexborneol or edaravone or excipients;

13. Have participated in other clinical studies or are participating in other clinicalstudies within 30 days before randomization;

14. Patients who are unwilling to be followed up，and the investigators consider thepatients are not suitable for this trial.