Study of the Benefit / Risk Ratio of Oral Anticoagulation in Hemodialysis Patients With Atrial Fibrillation
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 50
- 试验地点
- 20
- 主要终点
- Cumulative incidence of severe bleedings and thrombosis of oral anticoagulation versus no anticoagulation in hemodialysis patients with atrial fibrillation
研究概览
简要总结
Guidelines recommend oral anticoagulation with vitamin K antagonists for atrial fibrillation whenever the CHADS2VASC score is superior or equal to 2. As there are no specific guidelines for the hemodialysis patients with atrial fibrillation, the general guidelines apply. However, several retrospective studies suggest that these patients do not benefit from the oral anticoagulation regarding the risk of stroke and may even experience more bleedings and deaths.
The aim of this prospective study is to prospectively compare the hemorrhagic and thrombotic risks of oral anticoagulation in comparison with no anticoagulation in hemodialysis patients with 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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (≥ 18 years)
- •Patient on hemodialysis treatment for at least 1 month
- •Patient with a history of, or presenting a new episode of atrial fibrillation (either permanent or paroxysmal).
- •Patient with a CHADS2VASC score ≥2
- •Patient with high risk of bleeding as defined by (1) HASBLED score ≥3 OR (2) HASBLED ≥ CHADS2VASC score, OR (3) recent history of severe bleeding (type 3a, 3b, 3c), particularly cerebral or gastrointestinal, OR (4) prior recurrent (>2) history of falls.
- •Patient capable of understanding information about the study and of giving his/her consent
- •Patient informed of the preliminary medical exam results
- •Patient with healthcare insurance
- •Written consent signed
排除标准
- •Formal indication to oral anticoagulation beside atrial fibrillation (mechanic heart valves, recurrent thrombophlebitis, antiphospholipid syndrome)
- •Life expectancy < 6 months (e.g., terminal cancer)
- •Live donor transplantation scheduled within 6 months
- •Pregnancy (β-HCG blood-based assay)or nursing (lactating) women
- •Women of child bearing potential, unless they are using an effective method of birth control
- •Patient under legal guardianship
- •Patients under law protection
- •Known hypersensibility to coumadin or indoine derivatives or to any excipients (CI to oral AVK)
- •Severe liver failure (CI to oral AVK)
研究组 & 干预措施
No anticoagulation
No oral anticoagulation, and no monitoring of the INR.
干预措施: No oral anticoagulation (Biological)
Oral anticoagulation with vitamin K antagonists
VKA use as recommended in the guidelines with INR target range between 2 and 3. Daily administration or thrice weekly at the end of dialysis sessions upon Nephrologist's choice.
Antiplatelet therapy will be provided only if recent acute coronary syndrome (< 6 months) or active coronary stent. Aspirin should be preferred in dialysis patients as clopidogrel has an unpredictable reduced activity and there is no safety data on combination of VKA with prasugrel or ticagrelor in this population.
干预措施: Oral anticoagulation with vitamin K antagonists (Drug)
结局指标
主要结局
Cumulative incidence of severe bleedings and thrombosis of oral anticoagulation versus no anticoagulation in hemodialysis patients with atrial fibrillation
时间窗: 2 years
次要结局
未报告次要终点