Edaravone Dexborneol for Blood-Brain Barrier Repair in Acute Anterior Circulation Stroke

A Multicenter Randomized Controlled Trial Study of the Effect of Edaravone and Dexcamphan on the Repair of Blood-brain Barrier Injury in Acute Infarction of Anterior Circulation

This multicenter randomized controlled trial evaluates the effect of edaravone dexborneol on blood-brain barrier repair in patients with acute anterior circulation large artery atherosclerotic ischemic stroke within 48 hours of onset.

Patients are randomized 1:1 to receive either edaravone dexborneol (30mg/7.5mg BID IV) or edaravone (30mg BID IV) for 9±2 days, in addition to standard stroke treatment. The primary outcome is the change in blood-brain barrier permeability (Ktrans) measured by DCE-MRI. Secondary outcomes include neurological function scores, serum biomarkers, and safety events.

Study Overview

• Status: Recruiting
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Drug: Edaravone; Drug: Edaravone Dexborneol

• Study Type: Interventional
• Enrollment (Estimated): 432
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Qinjian Sun Qinjian; Phone Number: +86 15168885366; Email: sqj1210@163.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250021
      • Recruiting
      • Shandong Provincial Hospital Affiliated to Shandong First Medical University
      • Contact: Qinjian Sun Qinjian, Professor; Phone Number: +86 15168885366; Email: sqj1210@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Acute anterior circulation ischemic stroke within 48 hours of onset;
2. Age 35-80 years;
3. NIHSS score 4-24;
4. Pre-stroke mRS score ≤1;
5. Signed informed consent.

Exclusion Criteria:

1. Lacunar infarction or multiple punctate infarcts;
2. Intracranial hemorrhage;
3. Moyamoya disease, vasculitis, or other immune-related infarcts;
4. Combined tumor, intracranial infection, epilepsy, or severe systemic disease;
5. History of non-lacunar ischemic stroke within 6 months;
6. Severe liver or kidney dysfunction;
7. MRI contraindications;
8. Participating in other clinical trials.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group; Participants receive edaravone 30mg BID intravenous drip for 9±2 days, plus standard stroke treatment.	Drug: Edaravone; Edaravone 30 mg administered by intravenous drip twice daily (BID) for 9±2 days, in addition to standard guideline-based treatment for acute ischemic stroke.; Other Names: Edaravone Injection
Experimental: Intervention Group; Participants receive edaravone dexborneol 30mg/7.5mg BID intravenous drip for 9±2 days, plus standard stroke treatment.	Drug: Edaravone Dexborneol; Edaravone dexborneol (30 mg/7.5 mg) administered by intravenous drip twice daily (BID) for 9±2 days, in addition to standard guideline-based treatment for acute ischemic stroke.; Other Names: Edaravone and Dexborneol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Ktrans (blood-brain barrier permeability) measured by DCE-MRI	Change in the volume transfer constant (Ktrans) in the infarct region, quantifying the degree of blood-brain barrier repair from baseline (within 24-48 hours after onset) to day 9±2 after treatment, assessed by dynamic contrast-enhanced MRI (DCE-MRI).	From baseline (24-48 hours after stroke onset) to day 9±2 after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in serum Occludin level	Change in serum Occludin level measured by Simoa technology. Unit: pg/mL.	Baseline to day 9±2 post-treatment
Change in serum Fibronectin level	Change in serum Fibronectin level measured by Simoa technology. Unit: ng/mL.	Baseline to day 9±2 post-treatment
Change in serum MMP-9 level	Change in serum Matrix Metalloproteinase-9 (MMP-9) level measured by Simoa technology. Unit: ng/mL.	Baseline to day 9±2 post-treatment
Change in serum UCHL1 level	Change in serum Ubiquitin C-terminal Hydrolase L1 (UCHL1) level measured by Simoa technology. Unit: pg/mL.	Baseline to day 9±2 post-treatment
Change in serum NOS level	Change in serum Nitric Oxide Synthase (NOS) level measured by Simoa technology. Unit: assay-specific unit.	Baseline to day 9±2 post-treatment
Change in serum NSE level	Change in serum Neuron-Specific Enolase (NSE) level measured by Simoa technology. Unit: ng/mL.	Baseline to day 9±2 post-treatment
Change in serum GFAP level	Change in serum Glial Fibrillary Acidic Protein (GFAP) level measured by Simoa technology. Unit: pg/mL.	Baseline to day 9±2 post-treatment
Change in serum EAA level	Change in serum Excitatory Amino Acids (EAA) level measured by Simoa technology. Unit: µmol/L or assay-defined unit.	Baseline to day 9±2 post-treatment
NIHSS score at day 9±2	National Institutes of Health Stroke Scale (NIHSS) score. Higher scores indicate worse neurological deficit (Range: 0-42).	Day 9±2 after treatment
mRS score at day 9±2	modified Rankin Scale (mRS) score. Higher scores indicate worse functional outcome (Range: 0-6).	Day 9±2 after treatment
MMSE score at day 9±2	Mini-Mental State Examination (MMSE) score. Higher scores indicate better cognitive function (Range: 0-30).	Day 9±2 after treatment
MoCA score at day 9±2	Montreal Cognitive Assessment (MoCA) score. Higher scores indicate better cognitive function (Range: 0-30).	Day 9±2 after treatment
NIHSS score at day 90±7	National Institutes of Health Stroke Scale (NIHSS) score. Higher scores indicate worse neurological deficit (Range: 0-42).	Day 90±7 after treatment
mRS score at day 90±7	modified Rankin Scale (mRS) score. Higher scores indicate worse functional outcome (Range: 0-6).	Day 90±7 after treatment
MMSE score at day 90±7	Mini-Mental State Examination (MMSE) score. Higher scores indicate better cognitive function (Range: 0-30).	Day 90±7 after treatment
MoCA score at day 90±7	Montreal Cognitive Assessment (MoCA) score. Higher scores indicate better cognitive function (Range: 0-30).	Day 90±7 after treatment
Hemorrhagic transformation	Incidence of new cerebrovascular events during the study period.	From randomization to 90 days
New cerebrovascular events during the study	Incidence of new cerebrovascular events (including new ischemic stroke, transient ischemic attack, or other cerebrovascular events) in enrolled patients during the study period.	From randomization to day 90±7
Death during the study	All-cause mortality in enrolled patients during the study period.	From randomization to day 90±7
Other adverse events during the study	Incidence of other adverse events (AEs) in enrolled patients during the study period, excluding serious adverse events, hemorrhagic transformation, new cerebrovascular events, and death. Adverse events will be coded using MedDRA and summarized by system organ class and preferred term.	From randomization to day 90±7

Collaborators and Investigators

• Sponsor: Shandong Provincial Hospital
• Collaborators: Tengzhou Central People's Hospital; Zibo Central Hospital; Liaocheng People's Hospital; Shengli Oilfield Hospital; Dongying People's Hospital; Shandong Province Third hospital; Zaozhuang Municipal Hospital; Heze Municipal Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: June 14, 2026
• First Submitted That Met QC Criteria: November 10, 2026
• First Posted (Actual): November 12, 2026

Study Record Updates

• Last Update Posted (Actual): November 12, 2026
• Last Update Submitted That Met QC Criteria: November 10, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: ischemic stroke; neuroprotection; DCE-MRI; edaravone dexborneol; blood-brain barrier; large artery atherosclerosis
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Ischemic Stroke; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Pyrazoles; Antipyrine; Pyrazolones; Edaravone
• Other Study ID Numbers: SWYX:NO.2021-1020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No