A Trial of Edaravone Dexborneol in Acute Ischemic Stroke With Active Malignancy
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
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
Treatments tested in this trial
- edaravone dexborneol injection
- Standard therapeutic protocol
Treatment groups
144 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov