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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 4
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Qinjian Sun Qinjian
- Número de teléfono: +86 15168885366
- Correo electrónico: sqj1210@163.com
Ubicaciones de estudio
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Shandong
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Jinan, Shandong, Porcelana, 250021
- Reclutamiento
- Shandong Provincial Hospital Affiliated to Shandong First Medical University
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Contacto:
- Qinjian Sun Qinjian, Professor
- Número de teléfono: +86 15168885366
- Correo electrónico: sqj1210@163.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Acute anterior circulation ischemic stroke within 48 hours of onset;
- Age 35-80 years;
- NIHSS score 4-24;
- Pre-stroke mRS score ≤1;
- Signed informed consent.
Exclusion Criteria:
- Lacunar infarction or multiple punctate infarcts;
- Intracranial hemorrhage;
- Moyamoya disease, vasculitis, or other immune-related infarcts;
- Combined tumor, intracranial infection, epilepsy, or severe systemic disease;
- History of non-lacunar ischemic stroke within 6 months;
- Severe liver or kidney dysfunction;
- MRI contraindications;
- Participating in other clinical trials.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Control Group
Participants receive edaravone 30mg BID intravenous drip for 9±2 days, plus standard stroke treatment. |
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.
Otros nombres:
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Experimental: Intervention Group
Participants receive edaravone dexborneol 30mg/7.5mg BID intravenous drip for 9±2 days, plus standard stroke treatment. |
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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Ktrans (blood-brain barrier permeability) measured by DCE-MRI
Periodo de tiempo: From baseline (24-48 hours after stroke onset) to day 9±2 after treatment
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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
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in serum Occludin level
Periodo de tiempo: Baseline to day 9±2 post-treatment
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Change in serum Occludin level measured by Simoa technology. Unit: pg/mL. |
Baseline to day 9±2 post-treatment
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Change in serum Fibronectin level
Periodo de tiempo: Baseline to day 9±2 post-treatment
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Change in serum Fibronectin level measured by Simoa technology. Unit: ng/mL. |
Baseline to day 9±2 post-treatment
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Change in serum MMP-9 level
Periodo de tiempo: Baseline to day 9±2 post-treatment
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Change in serum Matrix Metalloproteinase-9 (MMP-9) level measured by Simoa technology. Unit: ng/mL. |
Baseline to day 9±2 post-treatment
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Change in serum UCHL1 level
Periodo de tiempo: Baseline to day 9±2 post-treatment
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Change in serum Ubiquitin C-terminal Hydrolase L1 (UCHL1) level measured by Simoa technology. Unit: pg/mL. |
Baseline to day 9±2 post-treatment
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Change in serum NOS level
Periodo de tiempo: Baseline to day 9±2 post-treatment
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Change in serum Nitric Oxide Synthase (NOS) level measured by Simoa technology. Unit: assay-specific unit. |
Baseline to day 9±2 post-treatment
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Change in serum NSE level
Periodo de tiempo: Baseline to day 9±2 post-treatment
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Change in serum Neuron-Specific Enolase (NSE) level measured by Simoa technology. Unit: ng/mL. |
Baseline to day 9±2 post-treatment
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Change in serum GFAP level
Periodo de tiempo: Baseline to day 9±2 post-treatment
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Change in serum Glial Fibrillary Acidic Protein (GFAP) level measured by Simoa technology. Unit: pg/mL. |
Baseline to day 9±2 post-treatment
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Change in serum EAA level
Periodo de tiempo: Baseline to day 9±2 post-treatment
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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
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NIHSS score at day 9±2
Periodo de tiempo: Day 9±2 after treatment
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National Institutes of Health Stroke Scale (NIHSS) score. Higher scores indicate worse neurological deficit (Range: 0-42). |
Day 9±2 after treatment
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mRS score at day 9±2
Periodo de tiempo: Day 9±2 after treatment
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modified Rankin Scale (mRS) score. Higher scores indicate worse functional outcome (Range: 0-6). |
Day 9±2 after treatment
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MMSE score at day 9±2
Periodo de tiempo: Day 9±2 after treatment
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Mini-Mental State Examination (MMSE) score. Higher scores indicate better cognitive function (Range: 0-30). |
Day 9±2 after treatment
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MoCA score at day 9±2
Periodo de tiempo: Day 9±2 after treatment
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Montreal Cognitive Assessment (MoCA) score. Higher scores indicate better cognitive function (Range: 0-30). |
Day 9±2 after treatment
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NIHSS score at day 90±7
Periodo de tiempo: Day 90±7 after treatment
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National Institutes of Health Stroke Scale (NIHSS) score. Higher scores indicate worse neurological deficit (Range: 0-42). |
Day 90±7 after treatment
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mRS score at day 90±7
Periodo de tiempo: Day 90±7 after treatment
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modified Rankin Scale (mRS) score. Higher scores indicate worse functional outcome (Range: 0-6). |
Day 90±7 after treatment
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MMSE score at day 90±7
Periodo de tiempo: Day 90±7 after treatment
|
Mini-Mental State Examination (MMSE) score. Higher scores indicate better cognitive function (Range: 0-30). |
Day 90±7 after treatment
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MoCA score at day 90±7
Periodo de tiempo: Day 90±7 after treatment
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Montreal Cognitive Assessment (MoCA) score. Higher scores indicate better cognitive function (Range: 0-30). |
Day 90±7 after treatment
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Hemorrhagic transformation
Periodo de tiempo: From randomization to 90 days
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Incidence of new cerebrovascular events during the study period. |
From randomization to 90 days
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New cerebrovascular events during the study
Periodo de tiempo: From randomization to day 90±7
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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
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Death during the study
Periodo de tiempo: From randomization to day 90±7
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All-cause mortality in enrolled patients during the study period. |
From randomization to day 90±7
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Other adverse events during the study
Periodo de tiempo: From randomization to day 90±7
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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
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Colaboradores e Investigadores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Trastornos cerebrovasculares
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Carrera
- Accidente cerebrovascular isquémico
- Compuestos heterocíclicos, 1 anillo
- Compuestos heterocíclicos
- Azoles
- Pirazoles
- Antipirina
- Pirazolonas
- Edaravona
Otros números de identificación del estudio
- SWYX:NO.2021-1020
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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