The Rhythm Evaluation for Anticoagulation with Continuous Monitoring of Atrial Fibrillation Trial (REACT-AF)

项目摘要/摘要 目的：持续监测心房颤动(反应)的抗凝节律评价 房颤)临床试验将比较两种预防心房卒中的治疗策略的有效性和安全性 纤颤(AF)：持续直接口服抗凝(DOAC)的当前标准与一种新的治疗策略 仅在房颤感应器检测到≥1小时房颤发作时才启动精确、有时间限制的DOAC 智能手表(AFSW(Apple Watch)) 理论基础：卒中风险通常与房颤的发病和持续时间有关，但出血风险持续存在。 即使在卒中风险可能较低的长时间无房颤期间，持续的抗凝暴露风险也是如此。反应- 房颤将评估在长时间的窦性心律期间保留抗凝的益处和风险 在空军特种部队的指导下。与连续DOAC相比，AFSW引导的、有时间限制的DOAC治疗可以 减少出血事件，同时保持对中风的保护。这有可能改善重要的主要临床 结果和生活质量，同时减少卫生保健的利用。 设计：Reaction-AF是一项多中心前瞻性、随机、开放标签、盲目终点试验(探针设计) 持续DOAC给药与有时间限制的DOAC的现行护理标准比较 有阵发性或持续性房颤病史的中低度房颤患者的房颤超声引导治疗 卒中风险(CHA2DS2-VASC评分1-4)。这项研究将有最初的解释阶段I，然后是 带有语用要素的第二阶段解释。 主要目标1(疗效目标)：评估AFSW指导的、有时间限制的DOAC治疗是否为非 低于持续DOAC治疗的复合终点包括：(1)缺血性卒中；(2)全身性 (3)全因死亡。 假设：对于复合材料，限定时间的DOAC疗法并不比持续DOAC疗法差。 缺血性中风、全身性栓塞和全因死亡的终点。 主要目标2(安全目标)：评估AFSW引导的、有时间限制的DOAC治疗是否显著 与持续的DOAC治疗相比，减少了重大出血事件。 假设：将参与者随机分配到AFSW引导、时间- 分隔式DOAC治疗与持续接受DOAC治疗的参与者进行比较。 探索性目标1：比较两组患者对抗凝治疗的总体满意度 两只学习臂。 探索性目标2：比较随机分成两组的参与者对卫生资源利用的估计 控制武器与实验武器。

Project Summary / Abstract Purpose: The Rhythm Evaluation for AntiCoagulaTion with Continuous Monitoring of Atrial Fibrillation (REACT AF) clinical trial will compare the efficacy and safety of two treatment strategies for stroke prevention in atrial fibrillation (AF): the current standard of continuous direct oral anticoagulation (DOAC) versus a novel strategy of precision, time-delimited DOAC initiated only in response to a ≥ 1-hour AF episode detected by an AF-sensing smartwatch (AFSW (Apple Watch)). Rationale: Stroke risk is often temporally related to AF onset and duration, but bleeding risk continues as a constant risk of anticoagulation exposure even during long AF-free periods when stroke risk may be low. REACT- AF will evaluate the benefits and risks of withholding anticoagulation during prolonged periods of sinus rhythm as guided by an AFSW. Compared with continuous DOAC, AFSW-guided, time-delimited DOAC treatment may reduce bleeding events while maintaining stroke protection. This has potential to improve important major clinical outcomes and quality of life while reducing health care utilization. Design: REACT-AF is a multicenter prospective, randomized, open label, blinded endpoint (PROBE design) trial comparing the current standard of care of continuous DOAC administration versus time-delimited DOAC treatment guided by an AFSW in patients with a history of paroxysmal or persistent AF and low-to-moderate stroke risk (CHA2DS2-VASc score 1-4). The study will have an initial explanatory phase I followed by an explanatory phase II with pragmatic elements. Primary Aim 1 (Efficacy Objective): To assess whether AFSW-guided, time-delimited DOAC therapy is non- inferior to continuous DOAC therapy for a composite endpoint that includes: (1) Ischemic Stroke; (2) Systemic embolism; (3) All-cause mortality. Hypothesis: Time-delimited DOAC therapy is non-inferior to continuous DOAC therapy for the composite endpoint of ischemic stroke, systemic embolism, and all-cause mortality. Primary Aim 2 (Safety Objective): To assess whether AFSW-guided, time-delimited DOAC therapy significantly reduces major bleeding events compared to continuous DOAC therapy. Hypothesis: Major bleeding events will be significantly lower in participants randomized to AFSW-guided, time- delimited DOAC therapy compared with participants receiving continuous DOAC therapy. Exploratory Aim 1: To compare overall participant satisfaction with anticoagulation management between the two study arms. Exploratory Aim 2: To compare estimates of health-related resource utilization in participants randomized to control versus experimental arms.