Randomized Evaluation of D-dimer Guiding Duration of Oral Anticoagulation Therapy in Patients With Bioprosthetic Heart Valves
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Thrombotic events
研究概览
简要总结
Guidelines recommended that patients with bioprosthetic heart valves (BHV) only need 6 months oral anticoagulation therapy after operation. However, a small part of patients still suffered thrombotic events after withdrawal of warfarin, which means these patients may need extend anticoagulation therapy. D-dimer, a sensitive marker of thrombosis or prethromboembolism state. Previous studies have demostrated that patients with elevated D-dimer levels have significant more clinical outcomes than those with nagative D-dimer levels. The aim of this study was to evaluate whether D-dimer could guide the duration of oral anticoagulation therapy in patients with BHV.
详细描述
Patients with BHV were screened and enrolled in this study. D-dimer levels were measured in the sixth months after BHV operation but before withdrawal of warfarin. Patients with elevated D-dimer were randomized to extend anticoagulation therapy group and routine stopping anticoagulation group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients received BHV within 3 months
排除标准
- •Recently throboemblism within 6 months
- •Recently bleedings within 3 months
- •Evaluated lifetime less than 2 years
研究组 & 干预措施
Extend anticoagulation group
Extended the duration anticoauglation to 12 months
干预措施: Warfarin Sodium (Drug)
结局指标
主要结局
Thrombotic events
时间窗: 24 months
Stroke, DVT, PE, valve thrombosis
Bleeding events
时间窗: 24 months
次要结局
未报告次要终点
研究者
Litao Zhang, MD
Head of anticoagulation clinic
Wuhan Asia Heart Hospital