This is a multicenter, randomized, double-blind, placebo-controlled, exploratory Phase II clinical trial. The goal of this clinical trial is to assess the safety and efficacy of edaravone dexborneol sublingual tablets for post-stroke cognitive impairment in patients with acute ischemic stroke. Participants will be required to receive 24 weeks treatment of edaravone dexborneol sublingual tablets or placebo during this study. The safety and efficacy endpoints will be compared in the patients with edaravone dexborneol sublingual tablets or placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
226
Patients will receive one edaravone dexborneol sublingual tablet twice daily for 24 weeks
Patients will receive one placebo twice daily for 24 weeks
Taihe County People's Hospital
Fuyang, Anhui, China
RECRUITINGHefei First People's Hospital
Hefei, Anhui, China
RECRUITINGThe First Affiliated Hospital of USTC Anhui Provincial Hospital
Hefei, Anhui, China
RECRUITINGThe Second People's Hospital of Hefei
Hefei, Anhui, China
RECRUITINGHuangshan City People's Hospital
Huangshan City, Anhui, China
RECRUITINGThe Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
RECRUITINGWuzhou Red Cross Hospital
Wuzhou, Guangxi, China
RECRUITINGThe Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
RECRUITINGZhumadian Central Hospital
Zhumadian, Henan, China
RECRUITINGThe Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
RECRUITING...and 11 more locations
Adverse Events
Adverse events (AE), treatment-related adverse events (TRAE), serious adverse events (SAE) in each group.
Time frame: Until follow up 26 weeks or early termination
Number of discontinuation/withdrawal patients
Discontinuation/withdrawal of patients in each group, including discontinuation due to adverse events.
Time frame: Until follow up 26 weeks or early termination
The changes of the Vascular Dementia Assessment Scale-cognitive subscale (VaDAS-Cog) scores.
The changes of the scores of the Vascular Dementia Assessment Scale-cognitive subscale (VaDAS-Cog) in each group after 24 weeks of treatment were compared with baseline. The minimum score is 0 and maximum score is 115 and the higher scores means the worse outcome.
Time frame: Until follow up 24 weeks
The incidence of Post Stroke Cognitive Impairment(PSCI )in each group
The incidence of PSCI in each group at the 12th and 24th week of treatment, defined as Proportion of patients with MoCA score \<22
Time frame: Week 12 and Week 24
The changes of Mini-Mental State Examination (MMSE) score
Mini-Mental State Examination (MMSE) at the 12th and 24th week of treatment (MMSE) score changes from baseline. The minimum score is 0 and maximum score is 30 and the higher scores means the better outcome.
Time frame: Week 12 and Week 24
The changes of Montreal Cognitive Assessment (MoCA) scale
Montreal Cognitive Assessment at the 12th and 24th week of treatment (MoCA) scale score changes from baseline. The minimum score is 0 and maximum score is 30 and the higher scores means the better outcome.
Time frame: Week 12 and Week 24
The changes of MoCA subscales
MoCA subscales (including visuospatial and execution) at the 12th and 24th week of treatment Function, naming, delayed recall, attention, language, abstraction, Orientation 7 subitems) from baseline. The minimum score is 0 and maximum score is 30 and the higher scores means the better outcome.
Time frame: Week 12 and Week 24
Modified Rankin Scale (mRS) scores
Modified Rankin Scale (mRS) scores at the 12th and 24th week of treatment. The minimum score is 0 and maximum score is 5 and the higher scores means the worse outcome.
Time frame: Week 12 and Week 24
The changes of National Institutes of Health Stroke Scale
National Institutes of Health Stroke Scale at the 4th,12th and 24th weeks of treatment (NIHSS) score changes from baseline. The minimum score is 0 and maximum score is 42 and the higher scores means the worse outcome.
Time frame: Week 4 , Week 12 and Week 24
The changes of the Vascular Dementia Assessment Scale-cognitive subscale (VaDAS-Cog) scores.
The changes of the scores of the Vascular Dementia Assessment Scale-cognitive subscale (VaDAS-Cog) in each group after 12 weeks of treatment were compared with baseline. The minimum score is 0 and maximum score is 115 and the higher scores means the worse outcome.
Time frame: Week 12
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