Investigation on Appropriate Duration of Dabigatran Use After Catheter Ablation for Paroxysmal Atrial Fibrillation in Patients With Low Thromboembolic Risk
试验速览
- 阶段
- 3 期
- 入组人数
- 464
- 主要终点
- The rate of thromboembolic events
研究概览
简要总结
The purpose of this study is to investigate the appropriate duration of dabigatran use after radiofrequency catheter ablation for paroxysmal atrial fibrillation in patients with low thromboembolic risk. According to the most recent guideline, anticoagulation is recommended to continue at least 2 months after the procedure. However bleeding risk with anticoagulant is also problematic. Post-procedural thrombosis is considered due to acute inflammation or char formation at the site of ablation, and these reaction occurs mostly within 1 month after the procedure. Also, the risk of thromboembolism is low in patients with CHA2DS2-VASc score less than 1. The investigators hypothesized that dabigatran use for the first 1 month after the RFCA for patients with paroxysmal AF and low thromboembolic risk would be sufficient for efficacy and safety compared to conventional dabigatran use for 2 months.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •paroxysmal AF undergoing catheter ablation
- •CHA2DS2-VASc score <= 1
- •informed consent
排除标准
- •persistent AF
- •CHA2DS2-VASc score > 2
- •prior CVA
- •prior atnicoagulant
- •severe HF
- •abnormal liver or renal function
- •history of severe bleeding
研究组 & 干预措施
Short Group
The patients taking dabigatran for 1 month after the radiofrequent catheter ablation for paroxysmal atrial fibrillation.
干预措施: dabigatran (Drug)
Conventional Group
The patients taking dabigatran for 2 months after the radiofrequent catheter ablation for paroxysmal atrial fibrillation.
干预措施: placebo (Drug)
结局指标
主要结局
The rate of thromboembolic events
时间窗: 2 months
次要结局
未报告次要终点
研究者
Young-Hoon Kim
Professor
Korea University Anam Hospital