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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 4
Kontakter og lokationer
Studiekontakt
- Navn: Qinjian Sun Qinjian
- Telefonnummer: +86 15168885366
- E-mail: sqj1210@163.com
Studiesteder
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Shandong
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Jinan, Shandong, Kina, 250021
- Rekruttering
- Shandong Provincial Hospital Affiliated to Shandong First Medical University
-
Kontakt:
- Qinjian Sun Qinjian, Professor
- Telefonnummer: +86 15168885366
- E-mail: sqj1210@163.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: 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.
Andre navne:
|
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Eksperimentel: 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.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Ktrans (blood-brain barrier permeability) measured by DCE-MRI
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in serum Occludin level
Tidsramme: 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
|
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Change in serum Fibronectin level
Tidsramme: 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
Tidsramme: 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
|
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Change in serum UCHL1 level
Tidsramme: 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
|
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Change in serum NOS level
Tidsramme: 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
|
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Change in serum NSE level
Tidsramme: 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
|
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Change in serum GFAP level
Tidsramme: 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
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Change in serum EAA level
Tidsramme: 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
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NIHSS score at day 9±2
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
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MoCA score at day 9±2
Tidsramme: Day 9±2 after treatment
|
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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Day 90±7 after treatment
|
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
Tidsramme: From randomization to 90 days
|
Incidence of new cerebrovascular events during the study period. |
From randomization to 90 days
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New cerebrovascular events during the study
Tidsramme: 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
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Death during the study
Tidsramme: From randomization to day 90±7
|
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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SWYX:NO.2021-1020
Plan for individuelle deltagerdata (IPD)
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