Safety and Efficacy of Vitamin K Antagonists Versus Rivaroxaban in Hemodialysis Patients With Atrial Fibrillation: a Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- composite of fatal and non-fatal stroke and other cardiovascular events
研究概览
简要总结
The investigators refer to the trial with clinicaltrials.gov indentifier NCT02610933 entitled Effect on Vascular Calcification of Replacing Warfarin by Rivaroxaban With or Without VitK2 in Hemodialysis Patients.
After termination of this trial, included patients will be asked to participate in the extension trial by continuing the treament of their respective allocation arm. No new intervention will be done.
详细描述
The investigators refer to the trial with clinicaltrials.gov indentifier NCT02610933 entitled Effect on Vascular Calcification of Replacing Warfarin by Rivaroxaban With or Without VitK2 in Hemodialysis Patients.
After termination of this trial, included patients will be asked to participate in the extension trial by continuing the treament of their respective allocation arm. No new intervention will be done. Relevant endpoints like death, cardiovascular events and bleeding episodes will be registered.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •inclusion in the trial with clinicaltrials.gov identifier NCT02610933
- •signed informed consent for this extension trial
排除标准
- 未提供
研究组 & 干预措施
Control
Hemodialysis patients with non valvular atrial fibrillation receiving warfarin
干预措施: Vitamin K Antagonist - Drug (Drug)
rivaroxaban
Hemodialysis patients with non valvular atrial fibrillation receiving rivaroxaban 10 mg od
干预措施: Rivaroxaban 10 MG Oral Tablet (Drug)
rivaroxaban + K2
Hemodialysis patients with non valvular atrial fibrillation receiving rivaroxaban 10 mg od + vitamin K2 supplements
干预措施: Rivaroxaban 10 MG Oral Tablet (Drug)
rivaroxaban + K2
Hemodialysis patients with non valvular atrial fibrillation receiving rivaroxaban 10 mg od + vitamin K2 supplements
干预措施: MK-7 2000µg thrice weekly (Dietary Supplement)
结局指标
主要结局
composite of fatal and non-fatal stroke and other cardiovascular events
时间窗: through study completion, on average 3 years
composite of fatal and non-fatal stroke and other cardiovascular events
次要结局
- death rate(through study completion, on average 3 years)
- safety: incidence of life-threatening, major and minor bleeding(through study completion, on average 3 years)
研究者
Rogier Caluwe
Principal Investigator
Onze Lieve Vrouw Hospital