University Hospitals Leuven, Department of Cardiovascular Medicine, Leuven, Belgium.
Am Heart J. 2012 Jun;163(6):931-937.e1. doi: 10.1016/j.ahj.2012.03.011.
Vitamin K antagonists are the only oral anticoagulants approved for long-term treatment of patients with a cardiac valve replacement.
This study aims to test a new dosing regimen for dabigatran etexilate in patients with a mechanical bileaflet valve.
Patients aged ≥ 18 years and ≤ 75 years, either undergoing implantation of a mechanical bileaflet valve (aortic or mitral or both) during the current hospital stay or having undergone implantation a mitral bileaflet valve >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.
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.
维生素 K 拮抗剂是唯一被批准用于长期治疗心脏瓣膜置换患者的口服抗凝药物。
本研究旨在测试达比加群酯在机械双叶瓣患者中的新剂量方案。
年龄≥18 岁且≤75 岁的患者，将在当前住院期间接受机械双叶瓣（主动脉瓣或二尖瓣或两者）植入术，或在随机分组前≥3 个月接受二尖瓣双叶瓣植入术，将以开放标签设计随机分为达比加群酯或华法林（2:1）组。达比加群酯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酯血浆谷水平来调整剂量，以在稳态时达到≥50ng/mL 的水平。剂量范围为每天两次 150mg 和每天两次 300mg。华法林的管理和目标国际标准化比值将根据治疗医生的判断，按照现行实践指南进行。计划用达比加群酯治疗 270 例患者，总研究人群约为 405 例。将以探索性方式分析临床疗效和安全性结局。
RE-ALIGN 是第一项在机械心脏瓣膜患者中测试华法林替代药物的研究。将根据本研究的结果计划进行一项确定性的 III 期研究。
