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

ConditionsIschemic Stroke, AcuteActive Malignancies
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorNanfang Hospital, Southern Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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);

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • edaravone dexborneol injection

    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

    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.

Treatment groups

144 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 2 interventions
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in NIHSS score from baseline to Day 30 post-treatment.

Time frame
From enrollment to the end of treatment at Day 30

Secondary outcomes

1

mRS score

Time frame
From enrollment to the end of treatment at Day 30 and Day 90
2

Proportion of patients with mRS score ≤2

Time frame
From enrollment to the end of treatment at Day 30 and Day 90
3

Change in NIHSS score

Time frame
From enrollment to the end of treatment at Day 14 and Day 90
4

Incidence of symptomatic intracranial hemorrhage transformation

Time frame
From enrollment to the end of treatment at 36-48 hours and 7 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nanfang Hospital, Southern Medical University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: