Actively Recruiting
Treatment of Acute Ischemic Stroke With Edaravone Dexborneol Sublingual Tablets in Small Vessel Disease
Led by Peking Union Medical College Hospital · Updated on 2025-09-26
600
Participants Needed
1
Research Sites
165 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of Edaravone Dexborneol Sublingual Tablets in patients with acute ischemic stroke due to small vessel disease (TASTE-SVD). The study will enroll approximately 600 participants aged 30 to 80 years who have experienced a recent small subcortical infarct (RSSI) confirmed by MRI. Participants will be randomized in a 1:1 ratio into either the Edaravone Dexborneol Sublingual Tablets group or the placebo group, with a 24-week treatment period followed by a 28-week follow-up. The primary endpoint is a hierarchical composite endpoint at week 24, including all-cause mortality, modified Rankin Scale (mRS) score ≥2, recurrent stroke, changes in MoCA score, and changes in VaDAS-Cog score. Secondary endpoints include additional functional and cognitive assessments at 24 and 52 weeks, as well as MRI markers of white matter hyperintensities, new infarctions, microbleeds, and brain atrophy. Safety assessments will include adverse events (AEs), treatment-related adverse events (TRAEs), and serious adverse events (SAEs). The study aims to determine whether Edaravone Dexborneol Sublingual Tablets improve functional outcomes and cognitive performance in patients with small vessel disease-related stroke.
CONDITIONS
Official Title
Treatment of Acute Ischemic Stroke With Edaravone Dexborneol Sublingual Tablets in Small Vessel Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 30 and 80 years
- MRI-confirmed recent small subcortical infarct (RSSI) with lesion size 6 mm
- White Matter Hyperintensity Fazekas score 62
- Stroke occurred within 3 weeks before randomization
- Pre-stroke Modified Rankin Scale (mRS) score 41
- No prior diagnosis of cognitive impairment or dementia
- At least primary school education and able to complete cognitive tests
- Women of childbearing potential and men with partners must use effective contraception during the study and for 30 days after last dose
- Female participants must have a negative pregnancy test before enrollment
- Signed informed consent form by participant or legal representative
You will not qualify if you...
- History of hemorrhagic stroke or bleeding disorders seen on brain imaging
- Severe consciousness impairment (NIHSS item 1a score >1)
- Presence of cortical infarcts, hydrocephalus, or other non-vascular white matter diseases
- Severe carotid artery stenosis requiring surgery (>50% stenosis)
- Systemic conditions affecting cognition like endocrine disorders or autoimmune diseases
- Neurological diseases linked to cognitive decline such as Parkinson's, epilepsy, brain tumors, or severe brain injury
- Severe psychiatric disorders including major depression or dementia unrelated to stroke
- Severe physical disability or language problems affecting cognitive testing
- Use of cognitive-enhancing drugs within 4 weeks before screening
- Severe liver or kidney disease or abnormal liver/kidney function tests
- Life expectancy less than 1 year due to serious systemic illness
- Contraindications to MRI such as incompatible implants or claustrophobia
- Known allergies to study drugs or excipients
- Pregnancy or breastfeeding
- Participation in another clinical trial within 30 days
- Any other medical, psychological, or social conditions making participation unsuitable
AI-Screening
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Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, China
Actively Recruiting
Research Team
Y
YiCheng Zhu, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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