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临床试验/NCT04121767
NCT04121767已完成不适用

Safety and Efficacy of Edoxaban Versus Warfarin in Patients Undergoing a Thoracoscopic Ablation for Persistent Atrial Fibrillation

Samsung Medical Center1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年12月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Postoperative stroke

研究概览

简要总结

The aim of this study is to compare the safety and efficacy of edoxaban and warfarin for prevention of stroke during a 6-month follow up after total thoracoscopic ablation.

详细描述

In Korea, 5% of patients older than 65 years and 10% of patients older than 80 have a history of atrial fibrillation (AF), which is often associated with sudden death and stroke. Medication and percutaneous radiofrequency catheter ablation are commonly used treatment modalities. Pharmacotherapy is primarily symptomatic treatment; moreover, the effect of conversion to a normal rhythm is minimal, and mainly aimed at stabilizing heart rate. Catheter ablation is associated with a high incidence of recurrence in chronic AF, and it is difficult to treat left atrial appendage, thereby preventing discontinuation of anticoagulation therapy post procedure. Thoracoscopic ablation is known to be a less invasive and more effective modality to treat patients with chronic atrial fibrillation. However, anticoagulation therapy is mandatory in the early postoperative period due to intracardiac thromboembolism associated with atrial stunning despite conversion to a sinus rhythm and resection of the left atrial appendage. Further investigation would be required to assess the efficacy and safety of novel oral anticoagulants such as edoxaban compared to that of warfarin for stroke prevention during the early postoperative period (6 months) after a thoracoscopic procedure. The need to maintain a constant level of blood coagulation and the potential development of complications such as hemorrhages are drawbacks associated with the use of warfarin. While novel oral anticoagulants such as edoxaban do have a role in atrial fibrillation, data regarding their effectiveness and incidence of complications after arrhythmia surgery do not exist. In this study, we will compare warfarin and edoxaban with respect to safety and efficacy, after they are used for 6 months following thoracoscopic ablation in patients with chronic atrial fibrillation

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

入选标准

  • Patients aged 18 years or older (not exceed 80 years old).
  • Elective thoracoscopic ablation.
  • Presence of atrial fibrillation (paroxysmal, persistent, long-standing persistent).

排除标准

  • Chronic obstructive pulmonary disease (COPD).
  • History of pulmonary tuberculosis.
  • Other cardiac comorbidities including valvular disease, coronary artery disease.
  • Congenital heart anomalies except for atrial septal defect.
  • Known, clinically important anemia or thrombocytopenia.
  • Pregnancy or lactation.
  • Malignancy.
  • Intracardiac mass or thrombus
  • Life expectancy less than 1 year.

研究组 & 干预措施

Edoxaban group

Experimental

patients prescribed edoxaban after thoracoscopic ablation during window period to prevent stroke

干预措施: Edoxaban (Drug)

Warfarin group

Active Comparator

patients prescribed warfarin after thoracoscopic ablation during window period to prevent stroke

干预措施: Warfarin (Drug)

结局指标

主要结局

Postoperative stroke

时间窗: 6 months

Number of patients showing thromboembolic neurologic complication after thoracoscopic ablation

次要结局

  • Postoperative bleeding(6 months)
  • Postoperative pericarditis(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dong Seop Jeong

Professor

Samsung Medical Center

研究点 (1)

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