比较慢性透析伴心房颤动患者使用华法林与不使用口服抗凝剂的随机对照试验方案：丹麦华法林-透析（DANWARD）试验。
Protocol for a randomised controlled trial comparing warfarin with no oral anticoagulation in patients with atrial fibrillation on chronic dialysis: the Danish Warfarin-Dialysis (DANWARD) trial.
机构信息
Department of Nephrology, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark
Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
出版信息
BMJ Open. 2024 Feb 26;14(2):e081961. doi: 10.1136/bmjopen-2023-081961.
INTRODUCTION
Atrial fibrillation is highly prevalent in patients on chronic dialysis. It is unclear whether anticoagulant therapy for stroke prevention is beneficial in these patients. Vitamin K-antagonists (VKA) remain the predominant anticoagulant choice. Importantly, anticoagulation remains inconsistently used and a possible benefit remains untested in randomised clinical trials comparing oral anticoagulation with no treatment in patients on chronic dialysis. The Danish Warfarin-Dialysis (DANWARD) trial aims to investigate the safety and efficacy of VKAs in patients with atrial fibrillation on chronic dialysis. The hypothesis is that VKA treatment compared with no treatment is associated with stroke risk reduction and overall benefit.
METHODS AND ANALYSIS
The DANWARD trial is an investigator-initiated trial at 13 Danish dialysis centres. In an open-label randomised clinical trial study design, a total of 718 patients with atrial fibrillation on chronic dialysis will be randomised in a 1:1 ratio to receive either standard dose VKA targeting an international normalised ratio of 2.0-3.0 or no oral anticoagulation. Principal analyses will compare the risk of a primary efficacy endpoint, stroke or transient ischaemic attack and a primary safety endpoint, major bleeding, in patients allocated to VKA treatment and no treatment, respectively. The first patient was randomised in October 2019. Patients will be followed until 1 year after the inclusion of the last patient.
ETHICS AND DISSEMINATION
The study protocol was approved by the Regional Research Ethics Committee (journal number H-18050839) and the Danish Medicines Agency (case number 2018101877). The trial is conducted in accordance with the Helsinki declaration and standards of Good Clinical Practice. Study results will be disseminated to participating sites, at research conferences and in peer-reviewed journals.
TRIAL REGISTRATION NUMBERS
NCT03862859, EUDRA-CT 2018-000484-86 and CTIS ID 2022-502500-75-00.
简介
心房颤动在慢性透析患者中高发。目前尚不清楚抗凝治疗预防卒中是否对这些患者有益。维生素 K 拮抗剂（VKA）仍然是主要的抗凝选择。重要的是，抗凝治疗的使用仍不一致，且在比较慢性透析患者口服抗凝治疗与不治疗的随机临床试验中，可能的益处尚未得到验证。丹麦华法林-透析（DANWARD）试验旨在研究慢性透析伴心房颤动患者使用 VKA 的安全性和疗效。假设与不治疗相比，VKA 治疗与降低卒中风险和总体获益相关。
方法与分析
DANWARD 试验是在丹麦 13 个透析中心开展的一项研究者发起的试验。采用开放标签随机临床试验设计，共将 718 例慢性透析伴心房颤动患者以 1:1 的比例随机分为两组，分别接受标准剂量 VKA 治疗，目标国际标准化比值为 2.0-3.0，或不接受口服抗凝治疗。主要分析将比较接受 VKA 治疗和不治疗的患者的主要疗效终点（卒中或短暂性脑缺血发作）和主要安全性终点（大出血）的风险。首例患者于 2019 年 10 月随机分组。患者将随访至纳入最后一名患者后 1 年。
伦理与传播
研究方案已获得地区研究伦理委员会（期刊号 H-18050839）和丹麦药品管理局（编号 2018101877）的批准。试验符合赫尔辛基宣言和良好临床实践标准。研究结果将在参与研究的机构、研究会议和同行评议期刊上进行传播。
试验注册号
NCT03862859、EUDRA-CT 2018-000484-86 和 CTIS ID 2022-502500-75-00。
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