Division of Cardiology, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.
Center for Medical Excellence, Faculty of Medicine, Chiang Mai, Thailand.
BMJ Open. 2021 Oct 11;11(10):e051987. doi: 10.1136/bmjopen-2021-051987.
The burden of atrial fibrillation (AF) in Thailand is high and associated with increased morbidity, mortality and healthcare costs. Vitamin K antagonists (eg, warfarin), commonly used for stroke prevention in patients with AF in Thailand, are effective but are often suboptimally controlled. We aim to evaluate the impact of an SAMe-TTR score-guided strategy and educational intervention compared to usual care on anticoagulation control expressed by the time in therapeutic range (TTR) at 12 months, in anticoagulant-naïve Thai patients with AF.
Multicentre, open-label, parallel-group, randomised controlled trial conducted in Thailand among adult patients (age: 18 years) with AF who are anticoagulant naïve. Patients will be randomised to one of two groups; an SAMe-TTR score-guided strategy with educational intervention and usual care versus usual care alone. The planned follow-up period is 12 months. The primary outcome is TTR at 12 months. Secondary outcomes include: (1) TTR at 6 months; (2) thromboembolic and bleeding events at 12 months; (3) composite major adverse cardiovascular events at 12 months; (4) change in patients' knowledge of AF between baseline and 6 months and 12 months; (5) cost effectiveness; (6) quality of life at baseline, 6 months and 12 months using EQ-5D-5L (Thai version) and (7) patient satisfaction/perceptions of the TREAT intervention. An embedded qualitative study will assess patient perceptions of the TREAT intervention.
The study has been approved by the Ethical Review Committee, Ministry of Public Health of Thailand, and registered in the Thai Clinical Trials Registry. The results of this trial will be submitted for publication in a peer-reviewed journal. Participants will be informed via a link to a preview of the publication. A lay summary will also be provided to all participants prior to publication.
TCTR20180711003.
在泰国，房颤（AF）的负担很重，与发病率、死亡率和医疗保健成本增加有关。维生素 K 拮抗剂（例如华法林）常用于泰国 AF 患者的卒中预防，虽然有效，但通常控制不佳。我们旨在评估 SAMe-TTR 评分指导策略和教育干预与常规护理相比，对 12 个月时抗凝控制的影响，表现为治疗范围内时间（TTR），在泰国无抗凝治疗的 AF 成年患者中。
在泰国进行的多中心、开放标签、平行组、随机对照试验，纳入无抗凝治疗的 AF 成年患者（年龄：18 岁）。患者将随机分为两组；SAMe-TTR 评分指导策略和教育干预与常规护理与常规护理单独比较。计划随访期为 12 个月。主要结局为 12 个月时的 TTR。次要结局包括：（1）6 个月时的 TTR；（2）12 个月时的血栓栓塞和出血事件；（3）12 个月时的主要不良心血管事件复合终点；（4）基线时与 6 个月和 12 个月时患者对 AF 的知识变化；（5）成本效果；（6）基线、6 个月和 12 个月时使用 EQ-5D-5L（泰国版）的生活质量；（7）患者对 TREAT 干预的看法和满意度。一项嵌入式定性研究将评估患者对 TREAT 干预的看法。
该研究已获得泰国公共卫生部伦理审查委员会的批准，并在泰国临床试验注册处注册。这项试验的结果将提交给同行评议期刊发表。通过链接向参与者提供预发表的内容。在发表之前，还将向所有参与者提供一份通俗摘要。
TCTR20180711003。
