A Phase III Case Series Clinical Study of the Reversal of the Anticoagulant Effects of Dabigatran by Intravenous Administration of 5.0g Idarucizumab (BI 655075) in Patients Treated Wtih Dabigatran Etexilate Who Have Uncontrolled Bleeding or Require Emergency Surgery or Procedures.RE-VERSE AD (A Study of the RE-VERSal Effects of Idarucizumab on Active Dabigatran) Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 503
- 试验地点
- 176
- 主要终点
- Maximum Reversal of Anticoagulant Effect of Dabigatran Based on Central Laboratory Determination of dTT or ECT
研究概览
简要总结
Evaluate the reversal of the anticoagulant effects of dabigatran by IV administration of 5.0g idarucizumab in patients treated with dabigatran etexilate who have uncontrolled bleeding or require emergency surgery or procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
idarucizumab
idarucizumab Only 1 treatment, no placebo or comparator
干预措施: idarucizumab (Drug)
结局指标
主要结局
Maximum Reversal of Anticoagulant Effect of Dabigatran Based on Central Laboratory Determination of dTT or ECT
时间窗: from the end of the first infusion up to 4 hours after the last infusion on Day 1
Maximum reversal of anticoagulant effect of dabigatran based on central laboratory determination of diluted thrombin time (dTT) or ecarin clotting time (ECT), at any time point from the end of the first infusion up to 4 hours after the last infusion. Reversal is defined for patients with at least one post-dose coagulation test results and pre-dose result higher than 100% ULN (evaluable patients). Reversal is calculated as 100\* (pre-dose value minus post dose value)/(pre-dose value minus 100% x ULN); if calculated reversal is \> 100, it was set to 100.
次要结局
- Reversal of aPTT and TT From Central Laboratory(from the end of the first infusion up to 4 hours after the last infusion on Day 1)
- Duration of Reversal(from the first infusion up to 24 hours after the last infusion on Day 1)
- Occurrence of Major/Life-threatening/Fatal Bleeding (for Group B Only) Intraoperatively(within 24 hours of surgery)
- Time to Cessation of Bleeding (for Group A Only)(from the first infusion up to 24 hours after the last infusion on Day 1)
- Cmin,1 of Unbound Sum (Free) Dabigatran(Since the end of first vial of idarucizumab up to 4 hours after the completion of second vial)
- Reversal of Anticoagulation as Measured by Diluted Thrombin Time (dTT) or Ecarin Clotting Time (ECT) After the First Vial of Idarucizumab and Before the Start of Second Vial(after the first vial of idarucizumab and before the start of second vial on Day1)