Development and Validation of a Full Course Bleeding Risk Assessment System for Antithrombotic Therapy of Acute Coronary Syndrome
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 6,379
- 试验地点
- 1
- 主要终点
- The number of event of bleeding
研究概览
简要总结
Antithrombotic therapy is the cornerstone of the management of patients with acute coronary syndrome (ACS), which result in lower risk of mortality and ischemic events. But, accompanied side effect of bleeding always causing worsens outcomes. Tools to evaluate risk/benefit ratio is useful in daily practice. The in-used scores, such as CRUSADE, are derived from retrospective studies, without all types of ACS and without long-term prediction. This project aims to establish a database of anti-thrombosis treatment and bleeding in five large centers in Beijing through the observational registry of ACS. With the database, establish a bleeding risk assessment system that can be used for all ACS patients and can predict the full course of antithrombotic treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age18-85 years old
- •Diagnosed ACS
- •Signed informed consent form
排除标准
- •Any active bleeding
- •Not tolerate to anti-thrombotic drugs
- •A planned elective surgical procedure that would necessitate an interruption in treatment with antiplatelet therapy in the next 6 months after enrollment
- •Patients who died of non-bleeding causes within 24 hours after admission
- •Noncardiac coexisting conditions that could limit life expectancy to less than 1 year
- •Pregnancy or lactation
结局指标
主要结局
The number of event of bleeding
时间窗: 1 year
The number of event of bleeding (BARC 2 to 5) within 1 year after enrollment
次要结局
- The number of event of bleeding(30 days and 1 year)
- number of event of major adverse cardiovascular or cerebrovascular events(30 days and 1 year)
研究者
Shao-Ping Nie
Professor of Medicine, Director, Emergency & Critical Care Center
Beijing Anzhen Hospital