Strategies for the Management of Atrial Fibrillation in patiEnts Receiving Dialysis (SAFE-D)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 151
- 试验地点
- 28
- 主要终点
- At least 80% of randomized participants remain in the trial and on the allocated study treatment at the end of the 26-week study period.
研究概览
简要总结
The prevention of atrial fibrillation related thromboembolism in the dialysis population is unclear. While the practice of anticoagulation appears favorable in patients with mild-to-moderate chronic kidney disease, no patients with severe chronic kidney disease (estimated glomerular filtration rate <25 ml/min), and specifically those receiving dialysis, have been included in randomized trials.Moreover, the effect of anticoagulation in the dialysis population may fundamentally differ from those studied in clinical trials. Accordingly, characterization of the optimal management strategy to reduce the risk of stroke and systemic embolism in patients with atrial fibrillation receiving dialysis is a priority. The overall goal of this pilot trial is to evaluate the feasibility of conducting a randomized controlled trial comparing anticoagulation strategies in patients with atrial fibrillation receiving dialysis (either hemodialysis or peritoneal dialysis).
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
- •Age ≥ 18 years.
- •Receiving maintenance hemodialysis or peritoneal dialysis for > 90 days.
- •History of AF or atrial flutter as defined by:
- •(i) AF or atrial flutter on a 12 lead ECG at enrollment, and not due to a reversible cause, or (ii) AF or atrial flutter documented on two separate occasions, not due to a reversible cause, at least 1 day apart prior to enrollment. AF or atrial flutter may be documented by ECG, or as an episode lasting at least 30 seconds on a rhythm strip or Holter recording, or more than 30 minutes if using pacemaker or implantable cardioverter defibrillator (ICD) recordings, or (iii) AF or atrial flutter documented on one occasion, not due to a reversible cause, prior to enrollment and being treated with an oral anticoagulant for AF or atrial flutter at enrollment. [AF or atrial flutter may be documented by ECG, or as an episode lasting at least 30 seconds on a rhythm strip or Holter recording, or more than 30 minutes if using pacemaker or implantable cardioverter defibrillator (ICD) recordings, or mentioned in the medical record], or (iv) AF or atrial flutter documented on one occasion on ECG, not due to a reversible cause, prior to enrollment and at least one more episode of AF or atrial flutter mentioned in the medical record, or (v) AF or atrial flutter documented on one occasion in a cardiologist report, not due to a reversible condition, prior to enrollment.
- •Satisfying CHADS-65 criteria: i) Age ≥65 or ii) Age <65 and one of: hypertension, diabetes mellitus, congestive heart failure, stroke/transient ischemic attack or peripheral embolism.
排除标准
- •Moderate or severe mitral stenosis.
- •Conditions other than non-valvular atrial fibrillation that require oral anticoagulation, such as mechanical prosthetic valve, deep venous thrombosis, or pulmonary embolism.
- •Need for aspirin at a dose > 165 mg a day, or need for aspirin in combination with P2Y12 antagonist therapy.
- •Need for an interacting drug which precludes the safe use of apixaban.
- •Life expectancy < 6 months.
- •Scheduled live-donor kidney transplant in the next 6 months.
- •A woman who is pregnant or breastfeeding or unwilling to pursue methods of contraception if < 12 months since the last menstrual period.
- •Co-enrollment in a clinical trial where the intervention is deemed to interfere with the adherence, safety or efficacy of the intervention provided herein.
- •Patient's attending physician(s) (e.g., nephrologist and/or cardiologist and/or neurologist) believes that oral anticoagulation is absolutely mandated.
- •Patient's attending physician(s) (e.g., nephrologist and/or cardiologist and/or neurologist) believes that oral anticoagulation is absolutely contraindicated.
研究组 & 干预措施
Warfarin
Individuals randomized to this arm will be exposed to dose-adjusted daily warfarin targeting an international normalized ratio (INR) of 2.0-3.0.
干预措施: Warfarin (Drug)
Apixaban
Individuals randomized to this arm will receive apixaban 5 mg twice daily (a reduced dose of 2.5 mg twice daily will be given to selected participants).
干预措施: Apixaban (Drug)
No oral anticoagulation
Individuals in this arm will be exposed to a treatment strategy in which no oral anticoagulation is prescribed.
干预措施: No oral anticoagulation (Other)
结局指标
主要结局
At least 80% of randomized participants remain in the trial and on the allocated study treatment at the end of the 26-week study period.
时间窗: 26 weeks
Recruitment of the target population within 2 years
时间窗: 2 years from start of trial
次要结局
- Non-fatal myocardial infarction(26 weeks)
- >95% of randomized patients adhere to the enrollment criteria with respect to atrial fibrillation or atrial flutter(End of trial)
- Major bleeding(26 weeks)
- Proportion of patients randomized to warfarin achieving a Time in the Therapeutic Range (TTR) >65%.(26 weeks)
- Clinically relevant non-major bleeding(26 weeks)
- Stroke and systemic embolism(26 weeks)
- Events of special interest related to dialysis access, the dialysis procedure or the oral anticoagulants(26 weeks)
- All cause mortality(26 weeks)
- Vascular events not related to dialysis access(26 weeks)