Effect of Butyphthalide on Cognitive Level Change After Cerebral Vascular Event-a Randomized Control Trial (Be-CLEVER)

PHASE3RecruitingINTERVENTIONAL
Enrollment

3,200

Participants

Timeline

Start Date

April 30, 2024

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
StrokePost-stroke Cognitive Impairment (PSCI)
Interventions
DRUG

dl-3-butylphthalide

"First stage: Routine stroke treatment: hypoglycemic, antihypertensive, antiplatelet, anticoagulant and other conventional cerebrovascular disease treatment drugs.~Placebo group: routine stroke treatment + oral Butylphthalide Placebo Soft Capsules, 2 capsules/time, tid, an empty stomach for 24 weeks.~Butylphthalide group: routine stroke treatment + oral Butylphthalide Soft Capsules, 2 capsules/time, tid, an empty stomach for 24 weeks.~Second stage: 14d washout period after first stage. Routine PSCI treatment: 5-10 mg Donepezil, qd. Placebo group: Routine PSCI treatment + oral Butylphthalide Placebo Soft Capsules, 2 capsules/time, tid, an empty stomach for 24 weeks.~Butylphthalide group:~Routine PSCI treatment + oral Butylphthalide Soft Capsules, 2 capsules/time, tid, an empty stomach for 24 weeks."

DRUG

dl-3-butylphthalide placebo

"First stage: Routine stroke treatment: hypoglycemic, antihypertensive, antiplatelet, anticoagulant and other conventional cerebrovascular disease treatment drugs.~Placebo group: routine stroke treatment + oral Butylphthalide Placebo Soft Capsules, 2 capsules/time, tid, an empty stomach for 24 weeks.~Butylphthalide group: routine stroke treatment + oral Butylphthalide Soft Capsules, 2 capsules/time, tid, an empty stomach for 24 weeks.~Second stage: 14d washout period after first stage. Routine PSCI treatment: 5-10 mg Donepezil, qd. Placebo group: Routine PSCI treatment + oral Butylphthalide Placebo Soft Capsules, 2 capsules/time, tid, an empty stomach for 24 weeks.~Butylphthalide group:~Routine PSCI treatment + oral Butylphthalide Soft Capsules, 2 capsules/time, tid, an empty stomach for 24 weeks."

Trial Locations (1)

Unknown

RECRUITING

Donggang Center Hospitol, Dandong

All Listed Sponsors
lead

Fudan University

OTHER