A Phase 4 interventional study of Edaravone and Edaravone Dexborneol in Acute Ischemic Stroke, sponsored by Shandong Provincial Hospital. Recruiting at 1 site in China. Open to participants aged 35 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Shandong Provincial Hospital · Phase 4, Interventional, and Treatment
Among 749 studies in Ischemic Stroke with a site in China — 376 open to participants now, 395 under way, 76 of them phase 3. Ischemic Stroke · China.
Among the 749 studies in Ischemic Stroke with a site in China, this one is the 200th largest by planned enrollment of the 563 interventional ones that give a count, is one of 55 that started in 2021, is one of 70 in phase 4, reaches primary completion later than 153 of the 394 other live ones, and was the 706th registered.
2,617 studies on the registry are indexed under Ischemic Stroke; 976 are open to participants now.
Browse Ischemic Stroke studies →376 of the 749 studies in Ischemic Stroke with a site in China are open now. Recruiting first, the newest first:
Xidian University · Sites in China
Ages 18+
The First Affiliated Hospital of Zhengzhou University · Sites in China
Ages 18+
Shanghai Jiao Tong University Affiliated Sixth People's Hospital · Sites in China
Ages 18–85
Yongjun Wang · Sites in China
Ages 18+
The First Affiliated Hospital of Anhui Medical University · Sites in China
Ages 18+
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 661 Ischemic Stroke studies recruiting now, 396 (60%) set no upper age limit and 62 (9%) stop at 75 or younger; 26 take children under 18; 42 take healthy volunteers.
This study: 35 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
749 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 42 · Phase 2 110 · Phase 3 134 · Phase 4 70
First in 2000; this study’s year is marked. 55 started in 2021.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 432 is above the median of 120 across 1,780 interventional studies indexed under Ischemic Stroke.
Median enrollment 266 across the 563 interventional studies, 625 across the 186 observational. Of the 235 that completed or were terminated, 10 (4%) have results posted.
This tab as a report to print or save as PDF → With an account.
79 of 749 have an industry lead sponsor. The 10 most frequent:
Shandong Provincial Hospital is the lead sponsor of 62 studies on the registry; 24 are open to participants now.
Shandong Provincial Hospital has 3 studies filed under Ischemic Stroke — fewer than ten, so there is no comparison to draw.
110 of the studies in Ischemic Stroke with a site in China that are under way reach primary completion within a year, 23 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06559241Phase 3Capital Medical UniversityRemote Ischemic Conditioning for Acute Ischemic Stroke Treated With Mechanical Thrombectomy（RECAST-MT） | 2026-11 |
| NCT06615726Phase 3Capital Medical UniversityRegular Physical Exercise in Patients With Symptomatic Intracranial Arterial Stenosis | 2026-11-19 |
| NCT06658197Phase 3Xuanwu Hospital, BeijingEfficacy and Safety of Tenecteplase Bridging Mechanical Thrombectomy for Acute Large Vessel Occlusion Stroke | 2026-12-01 |
| NCT06749834Phase 3Second Affiliated Hospital, School of Medicine, Zhejiang UniversityIntravenous Thrombolysis and NOAC | 2026-12-31 |
| NCT07335107Phase 3Beijing Tiantan HospitalIntravenous Tirofiban After Bridging Therapy for Acute Stroke With Atherosclerotic Large Artery Occlusion | 2027-01-31 |
Add all 110 to your calendar (.ics) → With an account.
Among the 749 studies in Ischemic Stroke with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive edaravone 30mg BID intravenous drip for 9±2 days, plus standard stroke treatment.
Drug: Edaravone
Participants receive edaravone dexborneol 30mg/7.5mg BID intravenous drip for 9±2 days, plus standard stroke treatment.
Drug: Edaravone Dexborneol
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.
Also known as: Edaravone Injection
Drug pages: 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.
Also known as: Edaravone and Dexborneol
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).
Time frame: From baseline (24-48 hours after stroke onset) to day 9±2 after treatment
Change in serum Occludin level
Change in serum Occludin level measured by Simoa technology. Unit: pg/mL.
Time frame: Baseline to day 9±2 post-treatment
Change in serum Fibronectin level
Change in serum Fibronectin level measured by Simoa technology. Unit: ng/mL.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Day 90±7 after treatment
Hemorrhagic transformation
Incidence of new cerebrovascular events during the study period.
Time frame: 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.
Time frame: From randomization to day 90±7
Death during the study
All-cause mortality in enrolled patients during the study period.
Time frame: 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.
Time frame: From randomization to day 90±7
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2021 (actual). Primary completion is estimated for Dec 2026, 62 months after the start.
Of 76 non-industry phase 4 interventional studies under Ischemic Stroke, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 42. This study's planned 62 months is above that.
Counting every sponsor, half of 85 studies reached it within 31 months; a quarter within 24 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drugs tested here: Edaravone · Dexborneol
Shandong Provincial Hospital