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

• Status: Not yet recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Qianfoshan Hospital
• Treatments: 3-n-butylphthalide

Criteria

Inclusion Criteria:

• 1. Female or male aged ≥ 18 years.

• 2. Acute ischemic stroke within 48 hours of onset

• 3. Examination to exclude intracranial hemorrhage

• 4. Provision of informed consent.

Exclusion Criteria:

• 1.Head CT or MRI suggests the presence of intracranial hemorrhagic disease

• 2.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

• 3.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

• 4.Allergy to Butylphthalide