Clinical trial · Interventional
A Trial of Edaravone Dexborneol in Acute Ischemic Stroke With Active Malignancy
A Prospective, Multicentre, Randomized Controlled Trial of Edaravone Dexborneol in Acute Ischemic Stroke With Active Malignancy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Active Malignancies | — | UNRESOLVED | — |
| Ischemic Stroke, Acute | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| edaravone dexborneol injection | Drug | — | UNRESOLVED |
| Standard therapeutic protocol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention group
- description
- Subjects randomized to the trial group will receive edaravone dexborneol injection at a dose of 37.5 mg (consisting of 30 mg edaravone and 7.5 mg dexborneol) administered twice daily with a fixed 12-hour interval between doses. The study drug will be diluted in 100 mL of normal saline and delivered via intravenous infusion over 30 minutes. This treatment regimen will be maintained for a duration of 10 to 14 days, in addition to standard stroke care. Strict adherence to the dosing schedule and infusion protocol will be ensured to maintain treatment consistency across study sites.
- interventionNames
- Drug: edaravone dexborneol injection
- Drug: Standard therapeutic protocol
- type
- ACTIVE_COMPARATOR
- label
- Control group
- description
- Subjects randomized to the control group will receive conventional standard therapy for acute ischemic stroke without the addition of edaravone dexborneol. The standard treatment regimen, which may include antiplatelet therapy, anticoagulation (if indicated), blood pressure management, and other evidence-based interventions, will be administered continuously for 10 to 14 days according to current clinical guidelines. All patients in this group will receive the same intensity of monitoring and follow-up as the experimental group to ensure comparable assessment of outcomes.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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; * Transient ischemic attack (TIA) as the current event; * Non-invasive skin cancers (e.g., basal cell carcinoma), primary central nervous system tumors, or hematologic malignancies; * 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); * Patients with severe psychiatric disorders or dementia; * 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; * 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; * Pregnancy, lactation, or planned pregnancy; * Participation in another clinical trial within 30 days prior to randomization or current enrollment in other interventional studies; * Any other condition deemed inappropriate for participation by the investigator.
References
Publications (0)
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