Edaravone Dexborneol for Blood-Brain Barrier Repair in Acute Anterior Circulation Stroke
NCT07933692, Phase 4, Recruiting, Shandong Provincial Hospital
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Edaravone Dexborneol for Blood-Brain Barrier Repair in Acute Anterior Circulation Stroke | ClinicalTrials.gov |
| NCT number | NCT07933692 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Phase 4 | ClinicalTrials.gov |
| Enrollment | 432 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Shandong Provincial Hospital | ClinicalTrials.gov |
| Conditions | Acute Ischemic Stroke | ClinicalTrials.gov |
| Interventions | Edaravone, Edaravone Dexborneol | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in Ktrans (blood-brain barrier permeability) measured by DCE-MRI | 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). | ClinicalTrials.gov |
| Secondary | Change in serum Occludin level | Baseline to day 9±2 post-treatment | Change in serum Occludin level measured by Simoa technology. Unit: pg/mL. | ClinicalTrials.gov |
| Secondary | Change in serum Fibronectin level | Baseline to day 9±2 post-treatment | Change in serum Fibronectin level measured by Simoa technology. Unit: ng/mL. | ClinicalTrials.gov |
| Secondary | Change in serum MMP-9 level | Baseline to day 9±2 post-treatment | Change in serum Matrix Metalloproteinase-9 (MMP-9) level measured by Simoa technology. Unit: ng/mL. | ClinicalTrials.gov |
| Secondary | Change in serum UCHL1 level | Baseline to day 9±2 post-treatment | Change in serum Ubiquitin C-terminal Hydrolase L1 (UCHL1) level measured by Simoa technology. Unit: pg/mL. | ClinicalTrials.gov |
| Secondary | Change in serum NOS level | Baseline to day 9±2 post-treatment | Change in serum Nitric Oxide Synthase (NOS) level measured by Simoa technology. Unit: assay-specific unit. | ClinicalTrials.gov |
| Secondary | Change in serum NSE level | Baseline to day 9±2 post-treatment | Change in serum Neuron-Specific Enolase (NSE) level measured by Simoa technology. Unit: ng/mL. | ClinicalTrials.gov |
| Secondary | Change in serum GFAP level | Baseline to day 9±2 post-treatment | Change in serum Glial Fibrillary Acidic Protein (GFAP) level measured by Simoa technology. Unit: pg/mL. | ClinicalTrials.gov |
| Secondary | Change in serum EAA level | 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. | ClinicalTrials.gov |
| Secondary | NIHSS score at day 9±2 | Day 9±2 after treatment | National Institutes of Health Stroke Scale (NIHSS) score. Higher scores indicate worse neurological deficit (Range: 0-42). | ClinicalTrials.gov |
| Secondary | mRS score at day 9±2 | Day 9±2 after treatment | modified Rankin Scale (mRS) score. Higher scores indicate worse functional outcome (Range: 0-6). | ClinicalTrials.gov |
| Secondary | MMSE score at day 9±2 | Day 9±2 after treatment | Mini-Mental State Examination (MMSE) score. Higher scores indicate better cognitive function (Range: 0-30). | ClinicalTrials.gov |
| Secondary | MoCA score at day 9±2 | Day 9±2 after treatment | Montreal Cognitive Assessment (MoCA) score. Higher scores indicate better cognitive function (Range: 0-30). | ClinicalTrials.gov |
| Secondary | NIHSS score at day 90±7 | Day 90±7 after treatment | National Institutes of Health Stroke Scale (NIHSS) score. Higher scores indicate worse neurological deficit (Range: 0-42). | ClinicalTrials.gov |
| Secondary | mRS score at day 90±7 | Day 90±7 after treatment | modified Rankin Scale (mRS) score. Higher scores indicate worse functional outcome (Range: 0-6). | ClinicalTrials.gov |
| Secondary | MMSE score at day 90±7 | Day 90±7 after treatment | Mini-Mental State Examination (MMSE) score. Higher scores indicate better cognitive function (Range: 0-30). | ClinicalTrials.gov |
| Secondary | MoCA score at day 90±7 | Day 90±7 after treatment | Montreal Cognitive Assessment (MoCA) score. Higher scores indicate better cognitive function (Range: 0-30). | ClinicalTrials.gov |
| Secondary | Hemorrhagic transformation | From randomization to 90 days | Incidence of new cerebrovascular events during the study period. | ClinicalTrials.gov |
| Secondary | New cerebrovascular events during the study | 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. | ClinicalTrials.gov |
| Secondary | Death during the study | From randomization to day 90±7 | All-cause mortality in enrolled patients during the study period. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)