Tests edaravone dexborneol in stroke patients who have active cancer
Tests edaravone dexborneol for acute ischemic stroke in adults with active cancer.
Plain-language title generated from the registry record
Registry title: A Trial of Edaravone Dexborneol in Acute Ischemic Stroke With Active Malignancy
Key facts
- Where
- Guangzhou, ChinaSee the site
- Phase
- Phase 4
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 80 who have had an acute ischemic stroke and also have an active cancer. It tests whether edaravone dexborneol injection helps recovery compared with standard care.
- Age
- 18 to 80 years (inclusive)
- Sex
- All sexes can join.
- Disease stage
- Acute ischemic stroke with symptoms starting 48 hours ago or less. NIHSS score of 4-24, with a combined score of 2 points or more on NIHSS items 5 and 6. Active cancer: diagnosed within 12 months before the stroke, metastatic disease, cancer treatment in the past 30 days, or cancer treatment declined.
- Earlier treatment
- People who use neuroprotective drugs (for example marketed edaravone, nimodipine, citicoline, piracetam or butylphthalide) cannot join.
Main reasons for not taking part
- Bleeding in the brain seen on head CT
- Pre-stroke modified Rankin Scale score above 1, or a transient ischemic attack as the current event
- Non-invasive skin cancer, primary brain tumor or blood cancer
- Liver or kidney problems, severe psychiatric disorder or dementia
- Pregnancy, breastfeeding or planned pregnancy
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07091994, who can take part
Where in China
- Nanfang Hospital, Southern Medical UniversityGuangzhou, ChinaContact: Jia Yin, M.DNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Nanfang Hospital, Southern Medical University
- Trial code
- NCT07091994
- Record updated
- 16 April 2026
- Original description
This multicenter randomized controlled trial aims to evaluate the efficacy and safety of edaravone dexborneol injection in patients with acute ischemic stroke (AIS) complicated by active malignancies. The study will primarily investigate whether this combined antioxidant and anti-inflammatory treatment can improve neurological functional recovery and assess its safety profile in this high-risk population. Investigators will compare outcomes between the edaravone dexborneol treatment group and a control group receiving standard therapy to determine if the intervention provides superior neuroprotective effects. Participants will receive the assigned treatment regimen, undergo serial neurological assessments and imaging studies to monitor stroke progression and recovery, and be closely followed for safety evaluations. The findings may offer evidence-based therapeutic options for managing this challenging clinical scenario where current treatment alternatives are limited.Read full original descriptionShow less
A Prospective, Multicentre, Randomized Controlled Trial of Edaravone Dexborneol in Acute Ischemic Stroke With Active Malignancy
This multicenter randomized controlled trial aims to evaluate the efficacy and safety of edaravone dexborneol injection in patients with acute ischemic stroke (AIS) complicated by active malignancies. The study will primarily investigate whether this combined antioxidant and anti-inflammatory treatment can improve neurological functional recovery and assess its safety profile in this high-risk population. Investigators will compare outcomes between the edaravone dexborneol treatment group and a control group receiving standard therapy to determine if the intervention provides superior neuroprotective effects. Participants will receive the assigned treatment regimen, undergo serial neurological assessments and imaging studies to monitor stroke progression and recovery, and be closely followed for safety evaluations. The findings may offer evidence-based therapeutic options for managing this challenging clinical scenario where current treatment alternatives are limited.
Inclusion: 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.
Exclusion: 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; 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; 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; Transient ischemic attack (TIA) as the current event; Pregnancy, lactation, or planned pregnancy.