A Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel Group, Multi-Center, Multi-National Study for Evaluation of Efficacy and Safety of Edoxaban (DU-176b) Versus Warfarin In Subjects With Atrial Fibrillation - Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation (ENGAGE - AF TIMI - 48)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 21,105
- 主要终点
- Compare Edoxaban to Warfarin for Superiority for Composite of Stroke and Systemic Embolic Events (SEE).
研究概览
简要总结
This study is to demonstrate the safety and efficacy profile, in two different dose regimens of Edoxaban (DU-176b), (an investigational new drug being tested for the prevention of stroke/systemic embolic events (SEE)), in individuals with atrial fibrillation. Patients will be randomized to one of three treatment groups: High Dose Regimen, Low Dose Regimen, & Warfarin. The expected duration of the study is 24 months.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •21 years of age or older; male or female.
- •Able to provide written informed consent.
- •History of documented AF within the prior 12 months
- •A moderate to high risk of stroke, as defined by CHADS2 index score of at least 2
排除标准
- •Transient atrial fibrillation secondary to other reversible disorders
- •Subjects with moderate or severe mitral stenosis, unresected atrial myxoma, or a mechanical heart valve
- •Subjects with any contraindication for anticoagulant agents;
- •Subjects with conditions associated with high risk of bleeding or have known or suspected hereditary or acquired bleeding disorders
- •Females of childbearing potential including the following:
- •Females with a history of tubal-ligation
- •Females less than 2 years post-menopausal
研究组 & 干预措施
Warfarin/placebo edoxaban
Warfarin tablets plus placebo Edoxaban tablets
干预措施: warfarin tablets (Drug)
Warfarin/placebo edoxaban
Warfarin tablets plus placebo Edoxaban tablets
干预措施: placebo edoxaban (Drug)
high dose edoxaban/placebo warfarin
Edoxaban tablets (60mg) plus warfarin placebo tablets
干预措施: Edoxaban tablets (high dose regimen-60mg) (Drug)
high dose edoxaban/placebo warfarin
Edoxaban tablets (60mg) plus warfarin placebo tablets
干预措施: placebo warfarin (Drug)
low dose edoxaban/placebo warfarin
Edoxaban tablets (30mg) plus warfarin placebo tablets
干预措施: Edoxaban tablets (low dose regimen-30mg) (Drug)
low dose edoxaban/placebo warfarin
Edoxaban tablets (30mg) plus warfarin placebo tablets
干预措施: placebo warfarin (Drug)
结局指标
主要结局
Compare Edoxaban to Warfarin for Superiority for Composite of Stroke and Systemic Embolic Events (SEE).
时间窗: overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up
Compare edoxaban to warfarin for the composite of stroke and Systemic Embolic Events (SEE) during the overall study period in the ITT analysis set with a superiority analysis.
Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE).
时间窗: overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up
The composite of stroke and Systemic Embolic Events (SEE) during the overall study period in the PP (per protocol) analysis set population.
次要结局
- Compare Edoxaban to Warfarin for Composite of Stroke, SEE, and All-cause Mortality(overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up)
- Adjudicated Bleeding Events(on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up)
- Compare Edoxaban to Warfarin for Composite of Stroke, Systemic Embolic Event (SEE), and Cardiovascular (CV) Mortality(overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up)
- Compare Edoxaban to Warfarin for Major Adverse Cardiac Event (MACE): a Composite of Non-fatal MI, Non-fatal Stroke, Non-fatal SEE, and Death Due to CV Cause or Bleeding(overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up)