RENal Hemodialysis Patients ALlocated Apixaban Versus Warfarin in Atrial Fibrillation (RENAL-AF) Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 154
- 试验地点
- 54
- 主要终点
- Number of Participants Experiencing ISTH (International Society on Thrombosis and Haemostasis) Major or Clinically Relevant Non-major Bleeding
研究概览
简要总结
This is a prospective, randomized, open-label, blinded end-point evaluation trial. The patient population consists of patients on hemodialysis who have atrial fibrillation (AF) and end-stage renal disease (ESRD) .
详细描述
This is a multicenter study in adult patients with AF and ESRD who are on hemodialysis and who have stroke risk factors making them candidates for oral anticoagulation. Patients will be randomized to apixaban versus warfarin, and will be treated for up to 15 months.
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
- •Males and females, age at least 18 years, or the local age of consent, whichever is greater.
- •Patients with AF defined as AF on ECG at enrollment or two or more reports of AF from separate monitoring events at least 2 weeks apart (report of ECG, Holter monitor, event monitor or implantable loop recorder).
- •CHA2DS2-VASc score of ≥
- •End-stage renal disease treated with hemodialysis for ≥ 3 months.
- •Considered by the treating physician(s) to be candidate for oral anticoagulation.
- •If of childbearing potential, be willing to avoid pregnancy during the study.
排除标准
- •Not considered by the treating physician(s) to be candidates for oral anticoagulation (for example, hemoglobin < 8.5g/dL, history of intracranial hemorrhage, active bleeding, recent gastrointestinal bleed or retroperitoneal bleed, severe hepatic impairment, or anaphylactic reaction to apixaban)
- •Moderate or severe mitral stenosis
- •Conditions other than AF that require anticoagulation such as mechanical prosthetic valve, deep venous thrombosis, or pulmonary embolism
- •Need for aspirin at a dose > 81 mg a day or need for P2Y12 antagonist therapy (for example clopidogrel, prasugrel, or ticagrelor)
- •Life expectancy < 3 months
- •Anticipated kidney transplant within the next 3 months
- •Prisoners or others who are involuntarily incarcerated or detained
- •Pregnant, breastfeeding, or considering pregnancy.
- •Participation in a clinical trial of an experimental treatment within the past 30 days
研究组 & 干预措施
apixaban
apixaban 5 mg twice daily (apixaban 2.5 mg twice daily for selected patients)
干预措施: apixaban (Drug)
warfarin
warfarin daily dose adjusted to target International Normalized Ration(INR) of 2-3
干预措施: warfarin (Drug)
结局指标
主要结局
Number of Participants Experiencing ISTH (International Society on Thrombosis and Haemostasis) Major or Clinically Relevant Non-major Bleeding
时间窗: Randomization up to Month 15/Final Visit
Assess the safety of apixaban versus warfarin regarding ISTH major bleeding or clinically relevant non-major bleeding events in patients with NVAF (nonvalvular atrial fibrillation) and ESRD (end-stage renal disease) on hemodialysis. Major bleeding event is defined as:Acute clinically overt bleeding (including access site related bleeding) accompanied by 1 or more of the following: Decrease in Hgb of 2g/dL or more with overt bleeding; Transfusion of 2 or more units of packed RBCs in the setting of an overt bleeding event; Bleeding within a critical site. Hemorrhagic stroke (primary or infarction with hemorrhagic conversion) were classified as major bleeds. Non-major bleeding event is defined as: Acute or sub-acute clinically overt bleeding (including access site related bleeding) that does not meet criteria for major bleeding \& results in Hospital admission for bleeding, physician guided medical or surgical treatment for bleeding, or change in antithrombotic therapy
次要结局
- Area Under the Plasma Apixaban Concentration Curve From 0 to 12 Hours After Dose (AUCO-12)(0-12 hours post-dose)
- Adherence to Treatment With Apixaban or With Warfarin(Month 15/Final Visit)
- Number of Participants Experiencing Mortality(Randomization up to Month 15/Final Visit)
- Persistence of Therapy(Randomization up to Month 15/Final Visit)
- Apixaban Plasma Concentration, Cmax(0-12 hours post-dose)
- Apixaban Pharmacodynamics, Chromogenic Factor Xa Assay(Baseline: Day 3, 4, or 5; Day 28)
- Apixaban Plasma Concentration, Cmin(0-12 hours post-dose)
- Number of Participants Experiencing Stroke or Systemic Embolism(Randomization up to Month 15/Final Visit)
研究者
Christopher Granger, MD
Professor of Medicine
Duke University