The Appropriate Anticoagulation Duration for Chronic Obstructive Pulmonary Disease With Pulmonary Thromboembolism-- A National Multicenter, Prospective, Randomized, Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 392
- 试验地点
- 1
- 主要终点
- Venous thromboembolism recurrence
研究概览
简要总结
Anticoagulation is the most important treatment for pulmonary thromboembolism (PTE). The thromboembolism risk is especially high in patients with chronic obstructive pulmonary disease (COPD) exacerbations. However, there's no agreement on the most appropriate duration of anticoagulation in COPD with PTE to balance the risk of recurrence of thrombosis and bleeding. This randomized, controlled trial aims to evaluate the risk and benefit of prolonged anticoagulation compared with the regular 3-month anticoagulation in COPD with PTE.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized patients due to chronic obstructive pulmonary disease exacerbation and diagnosed as newly developed pulmonary thromboembolism
- •Regular anticoagulation for 3 months and got CT pulmonary angiography
排除标准
- •Patients with major bleeding during prior anticoagulation
- •Patients need long term anticoagulation to treat other diseases
- •Patients unwilling to receive prolonged anticoagulation
研究组 & 干预措施
Prolonged anticoagulation
3 months longer anticoagulation after regular treatment
干预措施: Warfarin (Drug)
结局指标
主要结局
Venous thromboembolism recurrence
时间窗: 3 years
recurrence rate in %
次要结局
- Chronic obstructive pulmonary disease exacerbations(3 year)
研究者
Jianguo He
Chief of Pulmonary Vascular Disease Center
Chinese Academy of Medical Sciences, Fuwai Hospital