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

Study acronym: PRECISE AM
StatusNot Yet Recruiting
PhasePhase 4
Started2026-08-01
View on ClinicalTrials.gov ↗

Amendment history

2026-04-13
Study Identification, Study Status, Study Description, Eligibility v1
Start date2025-08-01→2026-08-01
Eligibility criteria-123 characters
Inclusion Criteria: 1. Age between 18 and 80 years (inclusive); 2. Diagnosis of acute ischemic stroke (AIS) according to the 2 [...] es 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 NIH [...] HSS Item 5 (upper limb motor) and Item 6 (lower limb motor); 5. Confirmed active malignancy before stroke onset or during h [...] lined cancer treatment (still considered active malignancy); 6. Signed informed consent obtained from the patient or legally authorized representative. Exclusion Criteria: [...] [...]
Study description-11 characters
[...] thereby potentially improving the outcomes of AIS patients. Our team's preliminaryPreliminary retrospective study demonstrated that edaravone dexborneol [...]
Study title-48 characters
A Prospective, Multicentre, Randomized Controlled Trial of Edaravone Dexborneol in Acute Ischemic Stroke With Active Malignancy
2025-07-21
Original filing
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.
Trial Details
NCT Number NCT07091994
Lead Sponsor Nanfang Hospital, Southern Medical University
Conditions Ischemic Stroke, Acute, Active Malignancies
Enrollment 144 participants
Start Date 2026-08-01
Primary Completion 2026-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-04-16