A Real-world Study on the Effectiveness and Safety of Butylphthalide in the Treatment of Ischemic Stroke.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- The incidence of adverse events caused by treatment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Intervention measures are closer to the real-world clinical environment to make up for the shortcomings of RCT.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or male aged ≥ 18 years.
- •Acute ischemic stroke within 48 hours of onset
- •Examination to exclude intracranial hemorrhage
- •Provision of informed consent.
排除标准
- •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
研究组 & 干预措施
A group of patients with ischemic stroke were treated with butylphthalide injection and capsules
Patients eligible for inclusion and exclusion are only divided into one group, no controls or other.
干预措施: Butylphthalide (Drug)
结局指标
主要结局
The incidence of adverse events caused by treatment
时间窗: 90 days
In a clinical trial, the probability of an unexpected and adverse medical event that occurs after a patient or clinical subject receives a trial drug, but it does not necessarily have a causal relationship with the treatment.
次要结局
- NIHSS(90 days)
- mRS(90 days)
- Correlation between blood drug concentration and adverse events(90 days)
研究者
Xin Huang
Chief Pharmacist
Qianfoshan Hospital