NCT02450682撤回2 期
Evaluate the Safety of Apixaban in Patients Who Undergo Cardiovascular Implantable Electronic Device (CIED) Procedure: A Randomized Pilot Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 试验地点
- 1
- 主要终点
- decrease in the hemoglobin level of 2 g per deciliter or more
研究概览
简要总结
This study is being done to determine if apixaban is more safe, when compared to warfarin, at reducing the risk of bleeding during CIED procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（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
Apixaban
Active Comparator
30 participants prescribed Apixaban 3-14 days before and 28 days after CIED procedure.
干预措施: Apixaban (Drug)
Warfarin
Other
30 participants will take stable dose of warfarin and go through the procedure without drug interrupt. The dose is adjusted by INR level. Length of treatment is 42 days, 14 days before and 28 days after the procedure.
干预措施: Warfarin (Drug)
结局指标
主要结局
decrease in the hemoglobin level of 2 g per deciliter or more
时间窗: 2 months
Assess the risk of major bleeding when continuing apixaban through the procedure as compared to Warfarin.
次要结局
未报告次要终点
研究者
研究点 (1)
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