NCT05068349

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.

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Qianfoshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Ischemic stroke is one of the diseases that seriously threaten human health, with the characteristics of high incidence, high disability and high recurrence rate. Patients will not only suffer from impaired physical function, but also mental symptoms, social function and other obstacles, which seriously affect the quality of life. Butylphthalide can improve the damage of central nervous system in patients with acute ischemic stroke, and can promote the improvement of patients with neurological deficits. Regarding the treatment of ischemic stroke with butylphthalide, there is still a lack of big data research based on real-world efficacy and safety; there is a lack of data on the pharmacokinetics of elderly patients and their correlation with adverse reactions. Thus, it is estimated that 300 patients will be enrolled and given intravenous butylphthalide sodium chloride injection 25mg twice a day for 7-14 days, and then oral butylphthalide soft capsule 0.2g three times a day for 76-83 days. The patients will be collected for experiment before and after treatment. Laboratory data, electrocardiogram, NIHSS, mRS, combined medication and adverse events, etc., to evaluate the effectiveness and safety of butylphthalide in the treatment of ischemic stroke. In addition, a population pharmacokinetic model of butylphthalide in elderly patients was established for 50 of them.

Conditions

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

Interventions

Type	Name	Description
DRUG	Butylphthalide	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.

Timeline

• Start date: 2022-05-07
• Primary completion: 2025-09-01
• Completion: 2025-12-01
• First posted: 2021-10-05
• Last updated: 2024-04-09

Locations

1 site across 1 country: China