Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 1:32 AM
NCT ID:
NCT07091994
Eligibility Criteria:
Inclusion Criteria:
* 1\. Age between 18 and 80 years (inclusive); 2. Diagnosis of acute ischemic stroke (AIS) according to the 2023 Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke; 3. Time from symptom onset to enrollment ≤48 hours; 4. 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); 5. 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); 6. Signed informed consent obtained from the patient or legally authorized representative.
Exclusion Criteria:
* Patients meeting any of the following criteria will be excluded: 1. Intracranial hemorrhagic diseases detected on head CT: hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc; 2. Pre-stroke modified Rankin Scale (mRS) score \>1; 3. Transient ischemic attack (TIA) as the current event; 4. Non-invasive skin cancers (e.g., basal cell carcinoma), primary central nervous system tumors, or hematologic malignancies; 5. 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); 6. Patients with severe psychiatric disorders or dementia; 7.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; 8.Severe systemic diseases with an expected survival \<90 days; 9. Pre-stroke Eastern Cooperative Oncology Group (ECOG) performance status ≥3; 10. Hypersensitivity to edaravone, (+)-borneol, or any excipients; 11. Pregnancy, lactation, or planned pregnancy; 12. Participation in another clinical trial within 30 days prior to randomization or current enrollment in other interventional studies; 13.Any other condition deemed inappropriate for participation by the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07091994
Study Brief:
Protocol Section:
NCT07091994