RecruitingPhase 4NCT05068349

For Patients With Ischemic Stroke, Clinically Study the Effectiveness and Safety of Butylphthalide.

A Real-world Study on the Effectiveness and Safety of Butylphthalide in the Treatment of Ischemic Stroke.

Sponsor

Qianfoshan Hospital

Enrollment

300 participants

Start Date

May 7, 2022

Study Type

INTERVENTIONAL

Conditions

Central Nervous System Diseases Stroke Nervous System Diseases Vascular Diseases Cerebral Infarction Brain Ischemia Brain Infarction

Summary

This is a prospective, open, single-arm, the real world of clinical trials. The researchers plan to recruit 300 eligible patients. The main purpose of this study is to evaluate the effectiveness and safety of butylphthalide in the treatment of ischemic stroke, and to establish a population pharmacokinetic model of butylphthalide in elderly patients to explore its blood drug concentration. Correlation with its efficacy and adverse reactions.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

\. Female or male aged ≥ 18 years.
\. Acute ischemic stroke within 48 hours of onset
\. Examination to exclude intracranial hemorrhage
\. Provision of informed consent.

Exclusion Criteria4

Head CT or MRI suggests the presence of intracranial hemorrhagic disease
Patients with cerebral embolism or suspected cerebral embolism with severe atrioventricular block disease, atrial fibrillation, myocardial infarction, heart valve disease, infective endocarditis, heart rate less than 50 beats per minute
Abnormal liver function (transaminase ALT or AST exceeding the upper limit of normal), abnormal renal function (creatinine exceeding the upper limit of normal), or suffering from other serious systemic diseases, etc
Allergy to Butylphthalide

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Interventions

DRUGButylphthalide

Butylphthalide sodium chloride injection 25mg, 2 times a day, 7-14 days, followed by 0.2g butylphthalide soft capsules, 3 times a day, 76-83 days, a total of 90 days.