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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- Phase 4
Contacts et emplacements
Coordonnées de l'étude
- Nom: Qinjian Sun Qinjian
- Numéro de téléphone: +86 15168885366
- E-mail: sqj1210@163.com
Lieux d'étude
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Shandong
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Jinan, Shandong, Chine, 250021
- Recrutement
- Shandong Provincial Hospital Affiliated to Shandong First Medical University
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Contact:
- Qinjian Sun Qinjian, Professor
- Numéro de téléphone: +86 15168885366
- E-mail: sqj1210@163.com
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: 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.
Autres noms:
|
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Expérimental: 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.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Ktrans (blood-brain barrier permeability) measured by DCE-MRI
Délai: From baseline (24-48 hours after stroke onset) to day 9±2 after treatment
|
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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in serum Occludin level
Délai: Baseline to day 9±2 post-treatment
|
Change in serum Occludin level measured by Simoa technology. Unit: pg/mL. |
Baseline to day 9±2 post-treatment
|
|
Change in serum Fibronectin level
Délai: Baseline to day 9±2 post-treatment
|
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
Délai: Baseline to day 9±2 post-treatment
|
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
Délai: Baseline to day 9±2 post-treatment
|
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
Délai: Baseline to day 9±2 post-treatment
|
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
Délai: Baseline to day 9±2 post-treatment
|
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
Délai: Baseline to day 9±2 post-treatment
|
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
Délai: Baseline to day 9±2 post-treatment
|
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
Délai: Day 9±2 after treatment
|
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
Délai: Day 9±2 after treatment
|
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
Délai: Day 9±2 after treatment
|
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
Délai: Day 9±2 after treatment
|
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
Délai: Day 90±7 after treatment
|
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
Délai: Day 90±7 after treatment
|
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
Délai: 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
|
|
MoCA score at day 90±7
Délai: Day 90±7 after treatment
|
Montreal Cognitive Assessment (MoCA) score. Higher scores indicate better cognitive function (Range: 0-30). |
Day 90±7 after treatment
|
|
Hemorrhagic transformation
Délai: From randomization to 90 days
|
Incidence of new cerebrovascular events during the study period. |
From randomization to 90 days
|
|
New cerebrovascular events during the study
Délai: From randomization to day 90±7
|
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
Délai: From randomization to day 90±7
|
All-cause mortality in enrolled patients during the study period. |
From randomization to day 90±7
|
|
Other adverse events during the study
Délai: From randomization to day 90±7
|
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
|
Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Troubles cérébrovasculaires
- Maladies du cerveau
- Maladies du système nerveux central
- Maladies du système nerveux
- Maladies vasculaires
- Maladies cardiovasculaires
- Accident vasculaire cérébral
- AVC ischémique
- Composés hétérocycliques, 1 anneau
- Composés hétérocycliques
- Azoles
- Pyrazoles
- Antipyrine
- Pyrazolones
- Édaravone
Autres numéros d'identification d'étude
- SWYX:NO.2021-1020
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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