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临床试验/NCT03073850
NCT03073850终止4 期

Antithrombotic Treatment in Patients With Effectively Maintained Sinus Rhythm After Atrial Fibrillation Ablation (The ATEMS-AF Study)

Korea University Guro Hospital4 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2017年2月23日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
入组人数
48
试验地点
4
主要终点
Freedom rate of stroke or systemic embolism during 2 years after successful AF ablation procedure

研究概览

简要总结

The purpose of the study is to investigate the best strategy for long-term stroke prevention in patients who have sinus rhythm after a successful catheter ablation for atrial fibrillation (AF) and who are at risk of thromboembolic events (CHA2DS2-VASc score ≥2). The investigators are going to compare antiplatelet therapy to oral anticoagulation (OAC) with different doses of edoxaban (30mg and 60mg).

详细描述

The investigators hypothesize that the strategy of OAC will be superior to antiplatelet therapy, but low dose edoxaban (30mg) will be non-inferior to standard dose edoxaban (60mg) for reducing the risk of stroke or systemic embolism in patients who underwent successful AF ablation. Although AF ablation is an effective therapy for reducing and/or eliminating the burden of AF, there may continue to be a risk of late recurrence or asymptomatic recurrence of atrial tachyarrhythmias. Until now, the guideline has recommended the continuation of OAC in patients who are at risk of stroke or systemic embolism based on the CHA2DS2-VASc score, even though they have maintained sinus rhythm. The annual rate of stroke, however, is still lower compared to that predicted by the scoring system, because AF ablation reduced the AF burden by 86% and the remaining episodes were significantly shorter in duration (median 6 minutes) than those pre-ablation reported by the previous study. Based on recent studies which demonstrated that both standard-dose and low-dose non-vitamin K OACs (NOAC) performed equally well with regard to the stroke prevention in patients with AF, low dose NOACs may also be sufficient for stroke prevention of briefly lasting AF episodes after successful AF ablation.

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

入选标准

  • Patients without evidence of any clinically apparent arrhythmia recurrence during at least six months after last catheter ablation of AF.
  • Willing and able to provide informed consent

排除标准

  • Patients who do not meet all of the above listed inclusion criteria.
  • Patients with significant valvular heart disease or mechanical valve.
  • Patients with hypertrophic cardiomyopathy.
  • Patients with chronic renal impairment with creatinine clearance rate of < 30 mg/dl.
  • Patients with contraindication to long-term OAC.
  • Patients who had a stroke within one year prior to enrolment.

研究组 & 干预措施

Antiplatelet therapy

Experimental

acetylsalicylic acid (ASA) 100mg or clopidogrel 75mg if intolerant to ASA

干预措施: Antiplatelet (Drug)

Low-dose OAC therapy

Experimental

Edoxaban of 30mg (Reduced dose of 15mg if body weight < 60kg, CCr< 50 ml/min, concomittant use of P-gp)

干预措施: Low dose oral anticoagulant (Drug)

Standard-dose OAC therapy

Active Comparator

Edoxaban of 60mg (Reduced dose of 30mg if body weight < 60kg, CCr< 50 ml/min, concomittant use of P-gp)

干预措施: Standard dose oral anticoagulant (Drug)

结局指标

主要结局

Freedom rate of stroke or systemic embolism during 2 years after successful AF ablation procedure

时间窗: 2 year

Check stroke or systemic embolism through neurologic examination or imaging studies

次要结局

未报告次要终点

研究者

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

Hong Euy Lim, MD

Professor

Korea University Guro Hospital

研究点 (4)

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