Registry of Bleeding Risk in Real World Chinese Acute Coronary Syndrome Patients-II
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 5,500
- 试验地点
- 1
- 主要终点
- the incidence of major bleeding during each visit
研究概览
简要总结
The present study was designed to observe the incidence of bleeding events and characteristics of bleeding and exploratively analyse bleeding related biomarkers and gene polymorphisms in ACS patients undergoing PCI.
详细描述
Acute coronary syndrome (ACS) is a group of clinical syndromes characterized by rupture or erosion of coronary atherosclerotic plaques secondary to complete or incomplete thrombus formation.
With the development of antithrombotic drugs and percutaneous coronary interventional therapy, bleeding has become one of the major complications for ACS patients after PCI.Moreover,Bleeding after PCI therapy significantly increased short-term and long-term risk of death.
However, there is a lack of data on the risk of bleeding in ACS patients treated with PCI in the clinical reality world of china.
Therefore,the present study was designed to observe the incidence of bleeding events and characteristics of bleeding and exploratively analyse bleeding related biomarkers and gene polymorphisms in ACS patients undergoing PCI.
The present study was designed to observe the incidence of bleeding events and characteristics of bleeding and exploratively analyse bleeding related biomarkers and gene polymorphisms in ACS patients undergoing PCI.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age≥18 years, male or female;
- •confirmed acute coronary syndrome patients;
- •undergo percutaneous coronary intervention (PCI) treatment;
- •agree to participate in this clinical study and sign a written consent form.
排除标准
- •ACS admission deemed secondary to other cause such as traffic accidents, trauma, severe upper gastrointestinal bleeding, surgery, or procedure;
- •patients who are not intend to attend 1 year of follow-up study or investigators find that patients are not able to comply with the study's requirements;
- •pregnant women or lactating women;
- •investigators consider patients who were not suitable for participation with other reasons
结局指标
主要结局
the incidence of major bleeding during each visit
时间窗: 12 months
Bleeding definition：According to the bleeding Academic Research Congress (BARC) standard;
次要结局
- the incidence of major adverse cardiovascular events during each visit(12 months)
研究者
Yun Dai Chen
Director of the Cardiovascular Department
Chinese PLA General Hospital