Comparison of Oral Anticoagulants for Extended VEnous Thromboembolism (COVET)
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Number of Subjects With Clinically Relevant Bleeding Events
研究概览
简要总结
Comparison of Oral anticoagulants (warfarin, apixaban and rivaroxaban) for extended VEnous Thromboembolism.
详细描述
Determine if apixaban is superior to warfarin in the reduction of clinically relevant bleeding. Determine if rivaroxaban is superior to warfarin in the reduction of clinically relevant bleeding. Determine if apixaban is non-inferior to warfarin in the prevention of recurrent venous thromboembolism. Determine if rivaroxaban is non-inferior to warfarin in the prevention of recurrent venous thromboembolism. An exploratory comparison of apixaban versus rivaroxaban for the prevention of clinically relevant bleeding and recurrent Venous Thromboembolism (VTEs) as a secondary objective.
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)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Warfarin
Subjects randomized to Warfarin will have warfarin administered daily in order to maintain a target INR of 2-3
干预措施: Warfarin (Drug)
Apixaban
Subjects randomized to Apixaban will have apixaban administered study drug of 2.5mg twice daily
干预措施: Apixaban 2.5 MG (Drug)
Rivaroxaban
Subjects randomized to Rivaroxaban will have rivaroxaban administered study drug of 10 mg daily
干预措施: Rivaroxaban 10 MG (Drug)
结局指标
主要结局
Number of Subjects With Clinically Relevant Bleeding Events
时间窗: Randomization to 12 months
Primary outcome of Clinically relevant bleeding (composite of major bleeding (MB) and/or clinically relevant non major bleeding (CRNMB))
Number of Subjects With Recurrent Venous Thromboembolism (VTE)
时间窗: Randomization to 12 months
Primary efficacy outcome of recurrent VTE
次要结局
未报告次要终点