Low-Dose Edoxaban Versus Very-Low-Dose Edoxaban in Elderly Patients With Atrial Fibrillation and a History of Stroke (LEAVE-Stroke): A Pragmatic Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- The proportion of patients achieving edoxaban concentrations within the expected range
研究概览
简要总结
This prospectively enrolled, pragmatic randomized trial aims to investigate whether very low dose edoxaban regimen (15 mg daily) achieves similar edoxaban concentrations as low dose edoxaban regimen (30 mg daily), while maintaining a comparable risk of clinical outcomes and reducing major bleeding in elderly patients with atrial fibrillation and a history of ischemic stroke or transient ischemic attack.
详细描述
Edoxaban, a factor Xa inhibitor, is used to prevent stroke or systemic thromboembolism (SSE) in patients with atrial fibrillation (AF). In elderly patients, the post-hoc analysis of the Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48 (ENGAGE AF-TIMI 48) trial showed that a low-dose edoxaban regimen (LDER, 30 mg daily) reduced the risk of major bleeding compared to the standard-dose edoxaban regimen (SDER, 60 mg daily), without an offsetting increase in SSE risk. Furthermore, the Edoxaban Low-Dose for Elder Care Atrial Fibrillation Patients (ELDERCARE AF) trial demonstrated that a very-low-dose edoxaban regimen (VLDER, 15 mg daily) was more effective than placebo for elderly patients where standard anticoagulant intensity posed safety concerns. Although both LDER and VLDER appear suitable for the elderly population, data comparing these two regimens are lacking.
Specific purpose:
To investigate whether VLDER (15 mg daily) achieves similar edoxaban concentrations as LDER (30 mg daily), while maintaining a comparable risk of clinical outcomes and reducing major bleeding in elderly patients with AF and a history of ischemic stroke (IS) or transient ischemic attack (TIA) through a pragmatic randomized trial.
Study design:
The Very Low-Dose Edoxaban in Elderly Atrial Fibrillation Patients with a History of Stroke (LEAVE-Stroke) trial is a prospective, multicenter, randomized trial. Elderly patients aged ≥ 80 years with AF, a history of IS/TIA and concerns about the bleeding risk of standard anticoagulant intensity will be enrolled. Participants will be randomized to either the VLDER or LDER group.
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
- 80 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age>=80 years
- •Has been diagnosed atrial fibrillation
- •Has history of ischemic stroke or transient ischemic attack
- •Has any of the bleeding risk lists below
- •bodyweight < 60 kg
- •creatinine clearance < 50 mL/min
- •history of major bleeding or gastrointestinal bleeding
- •concurrent use of antiplatelet agents (such as aspirin, clopidogrel, ticagrelor, prasugrel, cilostazol), non-steroidal anti-inflammatory drugs, amiodarone, tacrolimus, cyclosporine, dronedarone.
排除标准
- •Has ever used anticoagulants, defined as:
- •warfarin therapy within 1 month before study enrollment.
- •using heparin, low molecular weight heparin or direct oral anticoagulants within 7 days before study enrollment.
- •allergy to edoxaban
- •under regular dialysis, includes hemodialysis or peritoneal dialysis
- •refuse to provide informed consent.
研究组 & 干预措施
LDER
Patients will receive edoxaban 30 mg daily for stroke prevention.
干预措施: Edoxaban 30 mg (Drug)
VLDER
Patients will receive edoxaban 15 mg daily for stroke prevention.
干预措施: edoxaban (Drug)
结局指标
主要结局
The proportion of patients achieving edoxaban concentrations within the expected range
时间窗: 1 month
The proportion of patients achieving edoxaban concentrations within the expected range from the ENGAGE-AF TIMI 48 trial (12-43 ng/mL at trough) at 1 month.
次要结局
- Composite outcome(3 months)
- Major bleeding(3 months)
研究者
National Taiwan University Clinical Trial Center
Professor
National Taiwan University Hospital