Treatment of Acute Ischemic Stroke With Edaravone Dexborneol Sublingual Tablets in Small Vessel Disease
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age30-80
SponsorPeking Union Medical College Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age: Between 30 and 80 years .
MRI-confirmed recent small subcortical infarct (RSSI): A lesion in the small penetrating artery territory, detected as DWI hyperintensity and ADC hypointensity, with a maximum axial diameter ≤20 mm.
White Matter Hyperintensity (WMH) Burden: Fazekas score ≥2 (total score range: 0-6).
Time from Stroke Onset: ≤3 weeks from symptom onset to randomization.
Disqualifiers
Intracranial Hemorrhagic Diseases: Evidence of hemorrhagic stroke, epidural hematoma, subarachnoid hemorrhage, or other bleeding disorders detected by head imaging (MRI/CT).However, hemorrhagic transformation may be assessed by the investigator for potential inclusion.
Severe Consciousness Disturbance: NIHSS item 1a score >1 (indicative of significant impairment in consciousness).
Cortical Infarcts or Other Brain Abnormalities:Co-existing cortical infarcts, hydrocephalus, or other non-vascular white matter diseases (e.g., multiple sclerosis, carbon monoxide poisoning-related leukoencephalopathy).
Severe Carotid Artery Stenosis: Requiring surgical intervention (>50% stenosis).
Trial design
Design model
Parallel
Treatments tested in this trial
Edaravone Dexborneol Sublingual Tablets
DrugOne tablet of Edaravone Dexborneol Sublingual Tablet (containing 30mg Edaravone and 6mg Dexborneol) to be taken sublingually, twice daily.
Placebo
DrugOne placebo tablet, to be taken sublingually, twice daily
Treatment groups
600 Participants
are divided into 2 treatment groupsGroup A: Edaravone Dexborneol Sublingual TabletsExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Hierarchical Composite Endpoint
This composite outcome consists of five hierarchical endpoints at 24 weeks, analyzed using the Win Ratio method: 1. All-Cause Mortality 2. Modified Rankin Scale (mRS) Score ≥2 3. Stroke Recurrence 4. Change in Montreal Cognitive Assessment (MoCA) Score from Baseline 5. Change in Vascular Dementia Assessment Scale-Cognitive Subscale (VaDAS-Cog) Score from Baseline The Win Ratio approach will be used to analyze these outcomes in order of priority.
Time frame
24 weeks2
All-Cause Mortality
The number of participants who experience all-cause mortality at 24 weeks. All-cause mortality includes death from any reason, such as cardiovascular, neurological, or other systemic causes. This measure is used to assess the overall survival impact of the intervention.
Time frame
24weeks3
Modified Rankin Scale (mRS) Score ≥2
The proportion of participants with a modified Rankin Scale (mRS) score ≥2 at 24 weeks. The mRS is a widely used functional outcome measure that assesses the degree of disability or dependence in daily activities following a stroke. The scale ranges from 0 (no symptoms) to 6 (death), with scores of 2 or higher indicating functional dependence. A higher proportion of participants with mRS ≥2 suggests a worse functional outcome.
Time frame
24 weeks4
Stroke Recurrence
The number of participants who experience a recurrent stroke within 24 weeks of treatment. Recurrent stroke is defined as a new ischemic or hemorrhagic stroke occurring after the initial qualifying event, confirmed by neurological symptoms lasting ≥24 hours and neuroimaging evidence (MRI or CT). This measure assesses the effectiveness of the intervention in preventing subsequent strokes
Time frame
24 weeksSecondary outcomes
1
All cause mortality
The number of participants who experience all-cause mortality at 24 weeks. All-cause mortality includes death from any reason, such as cardiovascular, neurological, or other systemic causes. This measure is used to assess the overall survival impact of the intervention.
Time frame
24 weeks2
Modified Rankin Scale (mRS) Score ≥2
The proportion of participants with a modified Rankin Scale (mRS) score ≥2 at 24 weeks. The mRS is a widely used functional outcome measure that assesses the degree of disability or dependence in daily activities following a stroke. The scale ranges from 0 (no symptoms) to 6 (death), with scores of 2 or higher indicating functional dependence. A higher proportion of participants with mRS ≥2 suggests a worse functional outcome.
Time frame
24 weeks3
Stroke recurrence
The number of participants who experience a recurrent stroke within 24 weeks of treatment. Recurrent stroke is defined as a new ischemic or hemorrhagic stroke occurring after the initial qualifying event, confirmed by neurological symptoms lasting ≥24 hours and neuroimaging evidence (MRI or CT). This measure assesses the effectiveness of the intervention in preventing subsequent strokes
Time frame
24 weeks4
Post-stroke cognitive impairment
Number of participants with post-stroke cognitive impairment, defined as a MOCA score \< 22
Time frame
24 weeksSponsors and contacts
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Source ClinicalTrials.gov