A comparison of dabigatran etexilate with warfarin in patients with mechanical heart valves: The Randomized, phase II study to Evaluate the sAfety and pharmacokinetics of oraL dablGatran etexilate in patients after heart valve replacemeNt (RE-ALIGN)
A comparison of dabigatran etexilate with warfarin in patients with mechanical heart valves: The Randomized, phase II study to Evaluate the sAfety and pharmacokinetics of oraL dablGatran etexilate in patients after heart valve replacemeNt (RE-ALIGN)
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DOI：
10.1016/j.ahj.2012.03.011
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发表时间：
2012-06-01
影响因子：
4.8
通讯作者：
Eikelboom, John W.
中科院分区：
文献类型：
--
作者：
Van de Werf, Frans;Brueckmann, Martina;Eikelboom, John W.
背景 维生素 K 拮抗剂是唯一被批准用于心脏瓣膜置换术患者长期治疗的口服抗凝剂。 目的 本研究旨在测试机械双叶瓣膜患者达比加群酯的新给药方案。 方法 随机分组前年龄 >= 18 岁零 3 个月的患者将被随机分配到达比加群酯或华法林（以 比例为 2:1) 在开放标签设计中。达比加群的初始剂量将基于估计的肌酐清除率，并且将根据测量达比加群血浆谷浓度来调整剂量，以达到稳定状态下的水平> = 50 ng/mL。剂量范围为每天两次 150 毫克至每天两次 300 毫克。华法林管理和目标国际标准化比率将根据当前的实践指南由治疗医生酌情决定。该计划是用达比加群酯治疗 270 名患者，总研究人群约为 405 名患者。将以探索性的方式分析临床疗效和安全性结果。 结论 RE-ALIGN 是第一项在机械心脏瓣膜患者中测试华法林替代品的研究。将根据本研究的结果计划进行最终的 III 期研究。 （Am Heart J 2012；163：931-937.e1。）
Background Vitamin K antagonists are the only oral anticoagulants approved for long-term treatment of patients with a cardiac valve replacement.Objective This study aims to test a new dosing regimen for dabigatran etexilate in patients with a mechanical bileaflet valve.Methods Patients aged >= 18 years and 3 months before randomization, will be randomized between dabigatran etexilate or warfarin (in a ratio of 2:1) in an open-label design. Initial doses of dabigatran will be based on the estimated creatinine clearance, and the doses will be adjusted based on measuring trough dabigatran plasma levels to achieve levels >= 50 ng/mL at steady state. Doses will range between 150 mg twice a day and 300 mg twice a day. Warfarin management and target international normalized ratio will be according to current practice guidelines at the discretion of the treating physicians. The plan is to treat 270 patients with dabigatran etexilate for a total study population of approximately 405 patients. Clinical efficacy and safety outcomes will be analyzed in an exploratory manner.Conclusions RE-ALIGN is the first study to test an alternative to warfarin in patients with mechanical heart valves. A definitive phase III study will be planned based on the results of this study. (Am Heart J 2012;163:931-937.e1.)