Multivariate Analysis of Platelet Reactivity Variety in Patients With Coronary Heart Disease After PCI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Major adverse cardiovascular events
研究概览
简要总结
Study on the registration of coronary heart disease patients undergoing PCI in Chinese's population. Get the incidence of adverse events in these patients after PCI, a clear type of adverse reaction, forms, influencing factors, to establish risk management processes, clinical safety and reasonable treatment, and provide the basis for further research and reference.
详细描述
Dual antiplatelet therapy, comprising a low-dose aspirin and a kind of P2Y12 Receptor Inhibitors, has been the mainstay of the management in patients with acute coronary syndromes and/or undergoing Percutaneous Coronary Intervention (PCI). While variability to P2Y12 receptor inhibitors is common in patients and is a major cause of adverse cardiovascular events. Low response to P2Y12 receptor inhibitors will result high platelet reactivity (HPR) and patients who exhibit HPR are at increased risk of atherothrombotic occlusion events. Vice versa, high response to P2Y12 receptor inhibitors will lead to low platelet reactivity (LPR) and increase the risk of hemorrhage.Now, the absence of a universal definition of therapeutic window for different racial and actual clinical situations and lacking the gold standard test to quantify it limit the use in clinic practice.So this clinical trial try to use patient's platelet reactivity combine with type of adverse reaction, forms, influencing factors to find a proper therapeutic windows for P2Y12 receptor inhibitors in Chinese people.
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
- •Chinese's patients diagnosed with coronary heart disease and accept stent implantation.
- •Accept aspirin and P2Y12 receptor inhibitors (clopidogrel or ticagrelorwere）after stent implantation.
- •Willingness and ability to sign informed consent.
- •Can communicate effectively and complete the trial.
排除标准
- •Occurrence of a major complication during the procedure of percutaneous coronary intervention or before platelet function testing.
- •Allergy or intolerance to aspirin or P2Y12 receptor inhibitors (Clopidogrel or Ticagrelor）
结局指标
主要结局
Major adverse cardiovascular events
时间窗: within 1 year after PCI
ischemic and bleeding
次要结局
- Blood drug concentration(at 5-7 days, 1month, 3 months, 6 months and 12 months after taking anti-platelet agents)
- Mild to moderate adverse events(within 1 year after PCI)
- Platelet activity(at 12- 24 hours, 1 month, 3 months, 6 months and 12 months after PCI)