Safety and Efficacy of Edaravone Dexborneol for Acute Ischemic Stroke

Prior treatment

• Reperfusion therapy (intravenous thrombolysis and endovascular therapy) has been received or planned after stroke onset.
• Have participated in other clinical studies or are participating in other clinical studies within 30 days before randomization;

Other illness

• Posterior circulation stroke;
• Intracranial hemorrhagic diseases seen in head imaging: hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc;
• Patients with severe mental disorders and dementia;
• Complicated with malignant tumor or undergoing anti-tumor treatment;
• Therapeutic neuroprotective agents have been applied after onset of stroke, including commercially available edaravone, nimodipine, ganglioside, citicoline, piracetam, butyl benzene peptides, Urinary Kallidinogenase, Ginkgolide.
• Allergic to dexborneol or edaravone or excipients;

Lab values

• Severe cardiac insufficiency, dissection and acute pericarditis; Severe liver insufficiency, ALT or AST \> 3.0 × ULN; Or severe active liver diseases have been diagnosed, such as acute hepatitis, chronic active hepatitis, cirrhosis, etc;Severe renal insufficiency, Serum Creatinine (SCr) is greater than 200μmol/L, Creatinine Clearance (CrCl) is less than 30 ml/min or receiving hemodialysis; Or suffering from severe systemic diseases, the estimated survival time is less than 90 days;

Other

• Transient ischemic attack (TIA);
• Severe disturbance of consciousness: the item score of 1a consciousness level of NIHSS was more than 1;
• Systolic blood pressure after blood pressure control is still higher than 220mmhg or diastolic blood pressure was higher than 120mmhg;
• Patients during pregnancy, lactation and planned pregnancy;
• Patients who are unwilling to be followed up，and the investigators consider the patients are not suitable for this trial.

• Age ≥ 18 years old and ≤ 80 years old, regardless of gender;
• Patients diagnosed as acute ischemic stroke according to "key points for diagnosis of all kinds of major cerebrovascular diseases in China 2019", and able to randomise and initiate edaravone dexborneol treatment less than or equal to 48 hours of stroke onset.
• Total National Institute of Health stroke scale (NIHSS)≥6 and ≤24, and the sum of NIHSS score for the upper limb and the lower limb is greater than or equal to 2;
• modified Rankin Scale (mRS) score of 1 or less before onset.
• Did not receive edaravone dexborneol treatment before enrollment;
• The informed consent approved by the ethics committee was voluntarily signed by the patient or his legal representative.