AnticoaguLation ONE Year After Ablation of Atrial Fibrillation in Patients With Atrial Fibrillation (ALONE AF Study)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 840
- 试验地点
- 1
- 主要终点
- Composite outcome
研究概览
简要总结
There has no evidence for the anticoagulation in patients who had undergone catheter ablation of atrial fibrillation, and has maintained sinus rhythm for more than 1 year. However, anticoagulation can increase the risk of bleeding, the study evaluating the role of oral anticoagulation is needed in this patients. This study will compare the efficacy and safety of non-vitamin K anticoagulants (apixaban) and no oral anticoagulation in patient with sinus rhythm one year after catheter ablation of AF.
详细描述
This study is a prospective randomized study which was performed in multicenter (General Hospital) in Korea. Inclusion criteria is atrial fibrillation patients with moderate or high stroke risk (CHA2DS2-VASc>=1 male, and >=2 female) who had undergone catheter ablation of atrial fibrillation, and has maintained sinus rhythm for more than 1 year. Anticoagulation (Apixaban group) will take apixaban (5 mg bid or 2.5 mg bid according to dose guideline) for 2 years, and nonanticoagulation group will not take any oral anticoagulants for the same period. If the patients have the recurrence of AF, they will take anticoagulation according to standard treatment, and will be censored. We will analyze and compare the efficacy and safety of non-vitamin K anticoagulants (apixaban) and no oral anticoagulation in these patients.
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
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •no recurrence of atrial fibrillation one year after catheter ablation of atrial fibrillation
- •CHA2DS2-VASc score >=1 (male) or >=2 (female)
- •age: 19 to 80 years
- •non-valvular atrial fibrillation
- •those who consent the study.
- •those who can be followed after enrollment
排除标准
- •Severe liver or kidney dysfunction
- •Thyroid dysfunction
- •Pregnant or breastfeeding women
- •Malignant tumors that have not been completely cured
- •Severe structural heart disease
- •Predicted survival is less than 12 months
- •Patients who do not understand the content of the study or disagree with it
研究组 & 干预措施
Anticoagulation group(Apixaban group)
Apixaban 5mg twice daily (2.5mg twice daily if meets dose-reduction criteria) for 2 years
干预措施: Anticoagulation group(Apixaban group) (Drug)
结局指标
主要结局
Composite outcome
时间窗: 24 months
composite outcome including stroke/systemic embolism and major bleeding
次要结局
- Stroke(24 months)
- Major bleeding(24 months)
- Clinically Relivant Non-Major Bleeding (CRNMB)(Baseline, 1month, 6 month, 12 month, 18 month, 24 month)
- Death(Baseline, 1month, 6 month, 12 month, 18 month, 24 month)
- Transient ischemic attack (TIA)(Baseline, 1month, 6 month, 12 month, 18 month, 24 month)
- Hospital admission(Baseline, 1month, 6 month, 12 month, 18 month, 24 month)