A Trial of Edaravone Dexborneol in Acute Ischemic Stroke With Active Malignancy

Prior treatment

• Use of neuroprotective agents, including but not limited to: marketed edaravone, nimodipine, gangliosides, citicoline, piracetam, butylphthalide, human urinary kallidinogenase, or certain Chinese herbal medicines (see Concomitant Medications for details);
• Participation in another clinical trial within 30 days prior to randomization or current enrollment in other interventional studies;

Other illness

• Intracranial hemorrhagic diseases detected on head CT: hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc;
• Pre-stroke modified Rankin Scale (mRS) score \>1;
• Non-invasive skin cancers (e.g., basal cell carcinoma), primary central nervous system tumors, or hematologic malignancies;
• Patients with severe psychiatric disorders or dementia;
• Severe systemic diseases with an expected survival \<90 days;
• Pre-stroke Eastern Cooperative Oncology Group (ECOG) performance status ≥3;
• Hypersensitivity to edaravone, (+)-borneol, or any excipients;
• Any other condition deemed inappropriate for participation by the investigator.

Lab values

• Hepatic or renal dysfunction: ALT or AST \>3× upper limit of normal (ULN); Known liver diseases (e.g., acute/chronic active hepatitis, cirrhosis); Known kidney disease, renal insufficiency, serum creatinine \>1.5×ULN, or creatinine clearance \<50 mL/min;

Other

• Transient ischemic attack (TIA) as the current event;
• Pregnancy, lactation, or planned pregnancy;

• Age between 18 and 80 years (inclusive);
• Diagnosis of acute ischemic stroke (AIS) according to the 2023 Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke;
• Time from symptom onset to enrollment ≤48 hours;
• Presence of focal neurological deficits with a baseline NIHSS score of 4-24, and a combined score of ≥2 points on NIHSS Item 5 (upper limb motor) and Item 6 (lower limb motor);
• Confirmed active malignancy before stroke onset or during hospitalization, defined as: Cancer diagnosed within 12 months prior to stroke, Presence of metastatic disease, Received cancer-directed therapy within the past 30 days, or Patients who declined cancer treatment (still considered active malignancy);
• Signed informed consent obtained from the patient or legally authorized representative.