Effect of Butyphthalide on Cognitive Level Change After Cerebral Vascular Event-a Randomized Control Trial (Be-CLEVER) (Be-CLEVER)
Stroke, Post-stroke Cognitive Impairment (PSCI)
About this trial
This is an interventional treatment trial for Stroke focused on measuring stroke, PSCI, Butylphthalide
Eligibility Criteria
Inclusion Criteria: First stage: Acute ischemic stroke (AIS) symptom onset within 14 days Signs and symptoms consistent with the diagnosis of an acute ischemic stroke by CT/MRI. Age >= 60 years, Baseline NIHSS 3-18. Patient can complete questionnaire survey, physical examination, cranial MRI and other medical examinations Patient/legally authorized representative has signed the Informed Consent Form Second stage: Patient with stage I diagnosis of PSCI. Patient can complete questionnaire survey, physical examination, cranial MRI and other medical examinations. Patient/legally authorized representative has signed the Informed Consent Form Exclusion Criteria: First stage: Patients who had been diagnosed with dementia prior to stroke Other related factors affecting cognitive function: central nervous system infection, neurodegenerative diseases, trauma, poisoning, intracranial space occupying lesions, metabolic diseases, etc. Other serious central nervous system diseases: Parkinson's disease, epilepsy, multiple sclerosis, motor neurone disease, immune-related encephalomyelopathy, etc. Serious mental illness: anxiety disorder, depression, delirium, schizophrenia, bipolar disorder, mental retardation, which is diagnosed or controlled by medication. Uncorrectable visual and hearing impairments and inability to complete neuropsychological tests Severe liver and kidney dysfunction The presence of a malignant tumor or other serious/life-threatening disease that could cause the subject's death within 12 months. Current known alcohol or illicit drug abuse or dependence Patients undergoing thrombectomy, thrombolysis, carotid endarterectomy, or other surgical procedures during the acute infarction. Using cholinesterase inhibitors, N-methyl-D-aspartate (NMDA) receptor antagonists, or Sodium oligomannate (GV-971). Allergic to any component of butylphthalein Pregnancy or lactation, have the possibility of becoming pregnant, and who plan to become pregnant Participants in other interventional clinical trials MRI contraindications (e.g., claustrophobia, hypersensitivity to contrast media, etc.) Second stage: Patients did not take the study drug as prescribed, or discontinued the study drug, and were followed up for less than 24 weeks in the first stage. Recurrent stroke in the first stage Use drugs that may affect cognitive function
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
dl-3-butylphthalide
dl-3-butylphthalide Placebo
Routine treatment and dl-3-butylphthalide
Routine treatment and dl-3-butylphthalide Placebo