A Randomised, Phase II Study to Evaluate the sAfety and Pharmacokinetics of oraL dabIGatran Etexilate in Patients After Heart Valve replacemeNt
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 328
- 试验地点
- 40
- 主要终点
- Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations at Steady State (C Trough,ss) at Week 1
研究概览
简要总结
To validate the dosing algorithm for dabigatran etexilate in patients receiving a mechanical heart valve.
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
- 18 Years 至 75 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
Dabigatran etexilate
Patient dose dependent on screening CrCl levels and TT
干预措施: dabigatran etexilate intermediate dose (Drug)
Dabigatran etexilate
Patient dose dependent on screening CrCl levels and TT
干预措施: dabigatran etexilate low dose (Drug)
Dabigatran etexilate
Patient dose dependent on screening CrCl levels and TT
干预措施: dabigatran etexilate high dose (Drug)
warfarin
warfarin doses to maintain INR levels
干预措施: warfarin 1mg (Drug)
warfarin
warfarin doses to maintain INR levels
干预措施: warfarin 5mg (Drug)
warfarin
warfarin doses to maintain INR levels
干预措施: warfarin 3mg (Drug)
结局指标
主要结局
Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations at Steady State (C Trough,ss) at Week 1
时间窗: Week 1
Comparisons between dabigatran trough plasma levels as predicted by simulations to those observed in the study are performed to validate the dosing algorithm for Dabigatran Etexilate (DE) . Despite the primary endpoint only being assessed in patients who received dabigatran etexilate, Warfarin was included as a comparator treatment in this study in order to facilitate informal comparisons of outcome events, and to look for efficacy signals in this previously unexplored population.
Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at Week 2
时间窗: Week 2
Comparisons between dabigatran trough plasma levels as predicted by simulations to those observed in the study are performed to validate the dosing algorithm for Dabigatran Etexilate (DE). Despite the primary endpoint only being assessed in patients who received dabigatran etexilate, Warfarin was included as a comparator treatment in this study in order to facilitate informal comparisons of outcome events, and to look for efficacy signals in this previously unexplored population.
Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at Week 4
时间窗: Week 4
Comparisons between dabigatran trough plasma levels as predicted by simulations to those observed in the study are performed to validate the dosing algorithm for Dabigatran Etexilate (DE). Despite the primary endpoint only being assessed in patients who received dabigatran etexilate, Warfarin was included as a comparator treatment in this study in order to facilitate informal comparisons of outcome events, and to look for efficacy signals in this previously unexplored population.
Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at End of Trial (EoT) at Week 12
时间窗: Week 12
Comparisons between dabigatran trough plasma levels as predicted by simulations to those observed in the study are performed to validate the dosing algorithm for Dabigatran Etexilate (DE). (As the trial was stopped prematurely, EOT may not be 12 weeks after randomisation for most of the patients) Despite the primary endpoint only being assessed in patients who received dabigatran etexilate, Warfarin was included as a comparator treatment in this study in order to facilitate informal comparisons of outcome events, and to look for efficacy signals in this previously unexplored population.
次要结局
- Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at Week 1(Week 1)
- Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at Week 2(Week 2)
- Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at Week 4(Week 4)
- Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at End of Trial (EoT) Week 12(Week 12)