A Prospective, Multicentre, Randomized Controlled Trial of Edaravone Dexborneol in Acute Ischemic Stroke With Active Malignancy

NCT ID: NCT07091994

Last Updated: 2025-07-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2026-12-31

Brief Summary

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. Researchers 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.

Detailed Description

Patients with acute ischemic stroke (AIS) who also have active malignancies face a more complex clinical scenario, with limited treatment options and generally poor prognoses. The coexistence of these two conditions can interact through inflammatory and oxidative stress pathways, forming a vicious cycle that exacerbates the patient's condition. Edaravone dexborneol injection exhibits significant antioxidant and anti-inflammatory effects, effectively scavenging free radicals in the body, thereby potentially improving the outcomes of AIS patients. Our team's preliminary retrospective study demonstrated that edaravone dexborneol injection can promote neurological recovery in AIS patients with active malignancies and shows a favorable safety profile. Therefore, this study aims to conduct a multicenter randomized controlled trial to evaluate the efficacy and safety of edaravone dexborneol injection in treating AIS patients with active malignancies, with the goal of providing evidence-based medical support and more effective therapeutic strategies for this specific patient population.

Conditions

Ischemic Stroke, Acute; Active Malignancies

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intervention group

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.

Group Type: EXPERIMENTAL

edaravone dexborneol injection

Intervention Type: DRUG

The experimental intervention involved twice-daily administration of edaravone dexborneol injection at a dose of 37.5 mg (containing 30 mg edaravone and 7.5 mg dexborneol), with doses spaced exactly 12 hours apart. For each infusion, the study medication was first diluted in 100 mL of normal saline (0.9% sodium chloride solution) and then administered as a controlled intravenous infusion over a precisely timed 30-minute period. This standardized dosing regimen was maintained consistently throughout the 10-14 day treatment course for all participants in the experimental group.

Standard therapeutic protocol

Intervention Type: DRUG

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.

Control group

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.

Group Type: ACTIVE_COMPARATOR

Standard therapeutic protocol

Intervention Type: DRUG

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.

Interventions

edaravone dexborneol injection

The experimental intervention involved twice-daily administration of edaravone dexborneol injection at a dose of 37.5 mg (containing 30 mg edaravone and 7.5 mg dexborneol), with doses spaced exactly 12 hours apart. For each infusion, the study medication was first diluted in 100 mL of normal saline (0.9% sodium chloride solution) and then administered as a controlled intravenous infusion over a precisely timed 30-minute period. This standardized dosing regimen was maintained consistently throughout the 10-14 day treatment course for all participants in the experimental group.

Intervention Type: DRUG

Standard therapeutic protocol

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nanfang Hospital, Southern Medical University

Guangzhou, Baiyun, China

Countries

China

Central Contacts

Jia Yin, M.D

Role: CONTACT

jiajiayin@139.com

+8613802964883

Weike Hu, M.D

Role: CONTACT

weike946@gmail.com

+8618326349212

Facility Contacts

Jia Yin, M.D

Role: primary

jiajiayin@139.com

+8613802964883

Weike Hu, M.D

Role: backup

weike946@gmail.com

+8618326349212

Other Identifiers

NFEC-2025-303

Identifier Type: -

Identifier Source: org_study_id