跳至主要内容
临床试验/NCT03573037
NCT03573037Unknown不适用

Duration of Anticoagulation Therapy Following Catheter Ablation of Atrial Fibrillation; Randomized Controlled Trial

Yong Seog Oh1 个研究点 分布在 1 个国家目标入组 246 人开始时间: 2014年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
246
试验地点
1
主要终点
Thromboembolic event

研究概览

简要总结

The anticoagulation therapy is needed when rhythm control strategy is applied in atrial fibrillation patients but adverse events such as major bleeding exist. This study aims to examine the prognostic inpact of the duration of anticoagulation after radiofrequency ablation of paroxismal atrial fibrillation in patients with low thromboembolic risk. Paroxismal atrial fibrillation patients with 0 or 1 CHADS2-Vasc score undergoing radiofrequency ablation is randomized into one month anticoagulation group and two months anticoagulation group after the procedure. Thromboembolic event and adverse event including major or minor bleeding would be compared.

详细描述

Catheter based radiofrequency ablation has been used in more than a decade as a rhythm control therapy. Recently, superior outcome to medical therapy has been constantly reported and the radiofrequency catheter ablation (RFCA) became popular globally. It is recommended to anticoagulate patients who received RFCA for atrial fibrillation at least two months after the procedure. However, a few reports suggest anticoagulation in selective patients according to CHADS2-Vasc score. Anticoagulants prevent thromboembolic event in atrial fibrillation but the risk of bleeding is increased in company. There is controversy in the duration of anticoagulation after RFCA of atrial fibrillation. The investigators aimed to investigate the association with thromboembolic and bleeding event of anticoagulation duration after RFCA of atrial fibrillation in patients with low thromboembolic risk. Paroxismal atrial fibrillation patients with 0 or 1 CHADS2-Vasc score who are undergoing RFCA are included and randomized by 1:1 ratio to one month anticoagulation group and two months anticoagulation group after RFCA. Any patient with an evidence of intracardiac thrombus is excluded. The primary endpoint is thromboembolic event in 6 months after RFCA and the secondary endpoint is bleeding event in 6 months after RFCA.

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
— 至 74 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Under 75 years old Patients undergoing RFCA for paroxismal atrial fibrillation CHADS-Vasc score 0-1

排除标准

  • Presence of intracardiac thrombus

研究组 & 干预措施

1-month anticoagulation group

Experimental

Anticoagulation using warfarin or non-VKA oral anticoagulant for 1 month after radiofrequency catheter ablation of paroxismal atrial fibrillation and then stop anticoagulation.

干预措施: Oral anticoagulant (Drug)

2-month anticoagulation group

Active Comparator

Anticoagulation using warfarin or non-VKA oral anticoagulant for 2 months after radiofrequency catheter ablation of paroxismal atrial fibrillation and then stop anticoagulation

干预措施: Oral anticoagulant (Drug)

结局指标

主要结局

Thromboembolic event

时间窗: 6 months

Composite of ischemic stroke, transient ischemic attack, or other systemic embolic events

次要结局

  • Major bleeding(6 months)

研究者

发起方
Yong Seog Oh
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yong Seog Oh

professor

Seoul St. Mary's Hospital

研究点 (1)

Loading locations...

相似试验