NCT03051061Unknown不适用
Effect of Antithrombotic Treatment in Patients With Both Coronary Heart Disease and Atrial Fibrillation:A Single-center,Retrospective,Observational Study
Henan Institute of Cardiovascular Epidemiology1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2017年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Thromboembolism
研究概览
简要总结
The optimal antithrombotic treatment for Coronary Heart disease (CHD) patients combined with Atrial Fibrillation (AF) is unresolved at present. Although the European and American guidelines have given a hand for us, there is absence of real-world data on the safety and efficacy of antithrombotic therapy in Asian populations. Only a few clinical trials are available to guide difficult decision on antithrombotic therapy in patients with combined AF and CHD，the investigators highlight the need for the rapid development of clinical trials to close the large gaps in evidence. This research aims to know the real-world use of antithrombotic treatment and clinical prognosis in Coronary Heart Disease patients complicated with Atrial Fibrillation.
详细描述
- Our study is an observational, retrospective Study.
- Key date elements and definition of each variable were in line with the American Heart Association(AHA)/European Society of Cardiology(ECS） recommendation on AF and CHD. To reflect the contemporary antithrombotic management of AF and CHD in the past five years, the following data were collected: basic socio-demographic information, symptoms and signs relating to AF, medical history, results of physical examination and laboratory test.
- Follow-up time is at least 12 months. The patients will be asked about their medications and clinical outcomes by telephone interview or outpatient clinic. Then we will analyze the relative safety and efficacy of the various antithrombotic regimens.
- Based on the largest prospective study by Denmark about this issue, we anticipate an 30% incidence of composite outcome in the triple therapy arm. To achieve a precision of 10% with an α=0.05 and the rate of defaulters is 10%. The final estimated sample size was 986.
- Henan institute of cardiology epidemiology is responsible for design, date quality control and statistical analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Patients with chest pain and a significant lesion >50% angiographically.
- •Patients with a documented AF as confirmed by 12 leads ECG or Holter ECG.
排除标准
- •Rheumatic valvular disease.
- •Contraindications to oral anticoagulation.
- •Combined with other serious diseases with a life expectancy < 1 year.
结局指标
主要结局
Thromboembolism
时间窗: 1 year
including ischemic stroke and systemic embolization
次要结局
- Hemorrhage(1 year)
- Major Adverse Cardiovascular Events(MACE)(1 year)
- A composite outcome(1 year)
研究者
研究点 (1)
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