A Randomized Clinical Trial Comparing Three Anti-Thrombotic Strategies for Patients with Atrial Fibrillation and Severe Chronic Kidney Dysfunction
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,500
- 试验地点
- 6
- 主要终点
- Primary efficacy endpoint
研究概览
简要总结
VISIONAIRE (Vitamin K AntagonISt, Factor Xa Inhibitor Or Nothing In Atrial Fibrillation And DIalytic End-stage Renal DiseasE) trial will be a prospective randomized open-label with blinded endpoint adjudication trial including 1500 patients with atrial fibrillation or atrial flutter and advanced chronic kidney disease
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
- Single (Outcomes Assessor)
盲法说明
All study endpoints will be assessed by an independent Clinical Events Committee (CEC), whose members will be unaware of randomized treatment assignment.
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
- •Patients with clinical atrial fibrillation or flutter (persistent, paroxysmal or permanent);
- •CHA2DS2-Vasc ≥ 2 points (≥ 3 if female);
- •Chronic kidney disease with estimated glomerular filtration rate (eGFR) ≤ 15 ml/min/1.73 m2 by the CKD-EPI equation (confirmed by two lab results at least 3 months apart) or on chronic renal replacement therapy (Of note: number of patients included in no renal replacement therapy stratum will be capped at around 30% from the total study population).
排除标准
- •Active bleeding or severe bleeding < 1 month;
- •Prior kidney transplantation;
- •Refusal de provide consent
- •Severe chronic liver disease (Child C);
- •Other indication of oral anticoagulation (e.g.,: venous thromboembolism or pulmonary embolism);
- •Prior intracranial hemorrhage;
- •Bleeding disorder (other than uremia);
- •Platelet count < 50,000 / mm3 ;
- •Pregnancy or breastfeeding;
- •Mechanical valvar prosthesis;
- •Moderate to severe mitral stenosis;
- •Need for antithrombotic drugs other than single antiplatelet agents, or need for dual antiplatelet therapy with aspirin plus an ADP receptor blocker;
- •Any comorbidity beyond CKD and CV disease (e.g., metastatic cancer) which, in the investigator´s opinion, may impact survival in 12 months.
研究组 & 干预措施
Warfarin
Full-dose anticoagulation with adjusted dose (target INR 2.0-3.0) warfarin.
干预措施: Anticoagulant Oral (Drug)
Edoxaban
Dose will be based on label from Brazil considering adjustment for low CrCl, that is, 30 mg QD.
干预措施: Anticoagulant Oral (Drug)
结局指标
主要结局
Primary efficacy endpoint
时间窗: 24 months (median follow-up)
Time to first occurrence of the composite of stroke or systemic embolism
Primary safety endpoint:
时间窗: 24 months (median follow-up)
Major or clinically relevant non-major bleeding according to the ISTH criteria
次要结局
- Net clinical endpoint(24 months (median follow-up))
- Secondary efficacy endpoints(24 months (median follow-up))
- Secondary safety endpoint(24 months (median follow-up))