Real-world Study on the Efficacy and Safety of Ticagrelor in the Treatment of Ischemic Cerebrovascular Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- Correlation between blood drug concentration and adverse events
研究概览
简要总结
This is a forward-looking, open, one-arm, and real clinical trial world. The researchers plan to recruit at least 50 qualified patients. The main purpose of this study is to establish a population pharmacokinetic model of ticagrelor , explore the correlation between its blood concentration and the events of ischemia and the adverse effects of hemorrhage, and evaluate the effectiveness and safety of ticagrelor in the treatment of ischemic cerebrovascular disease.
详细描述
Ischemic stroke and transient ischemic attack are the most common types of ischemic cerebrovascular disease. Patients will suffer from physiological function damage, even mental symptoms, social function and other obstacles, seriously affecting the quality of life, and bringing heavy burden to families and society.
Ticagelor is a new P2Y12 receptor antagonist. Compared with clopidogrel, ticagelor has stronger and more lasting platelet inhibition, and can reduce the recurrence of ischemic events in patients with acute coronary syndrome .
Therefore, at least 50 patients with ischemic cerebrovascular disease using ticagelor will be included. Before and after treatment, the laboratory examination data, NIHSS, mRS, combined medication and adverse events, and ischemic events of the patients will be collected. The population pharmacokinetics model of Ticagelor was established to evaluate its effectiveness and safety.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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.
- •Clinically diagnosed as ischemic cerebrovascular disease.
- •Take ticagelor for antiplatelet therapy.
- •Provision of informed consent.
排除标准
- •Head CT or MRI suggests the presence of intracranial hemorrhagic disease.
- •People with tumors and other serious systemic diseases.
- •Allergy to ticagelor.
结局指标
主要结局
Correlation between blood drug concentration and adverse events
时间窗: 6 months
Try to find the relationship between pharmacokinetic parameters and adverse events
次要结局
- NIHSS(6 months)
- mRS(6 months)
- The incidence of adverse events caused by treatment(6 months)
研究者
Xin Huang
Chief pharmacist
Qianfoshan Hospital