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

心房颤动连续监测试验的抗凝节律评估 (REACT-AF)

• 批准号: 10725186
• 负责人: ROD S PASSMAN
• 金额: $ 634.45万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-25 至 2029-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10725186
• 关键词: Rhythm; Evaluation; Anticoagulation; Continuous; Monitoring

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.

项目总结/摘要 目的：房颤持续监测下抗凝治疗的节律评价 AF）临床试验将比较两种治疗策略预防心房纤颤患者卒中的有效性和安全性。 房颤（AF）：当前标准的持续直接口服抗凝（DOAC）与新的 仅在AF感知检测到≥ 1小时AF发作时启动精确、时间限定的DOAC 智能手表（AFSW（Apple Watch））。 依据：卒中风险通常与房颤发作和持续时间存在时间相关性，但出血风险持续存在， 即使在卒中风险可能较低的长期无AF期间，抗凝暴露的风险也是恒定的。反应- AF将评估在窦性心律延长期间停止抗凝治疗的获益和风险 由一名武装部队士兵指挥与连续DOAC相比，AFSW引导的、时间限定的DOAC治疗可能 减少出血事件，同时保持中风保护。这有可能改善重要的主要临床 结果和生活质量，同时减少医疗保健利用。 设计：REACT-AF是一项多中心、前瞻性、随机、开放标签、设盲终点（PROBE设计）试验 比较持续DOAC管理与时间限定DOAC管理的当前护理标准 在有阵发性或持续性AF病史和低至中度AF的患者中，由AFSW指导治疗 卒中风险（CHA 2DS 2-VASc评分1-4）。这项研究将有一个初步的解释性阶段， 第二阶段的解释与务实的元素。 主要目的1（有效性目的）：评估AFSW指导的、时间限定的DOAC治疗是否为非 在复合终点方面劣于持续DOAC治疗，包括：（1）缺血性卒中;（2）全身性 栓塞;（3）全因死亡。 假设：对于复合终点，时间限定DOAC治疗不劣于连续DOAC治疗 缺血性中风、全身性栓塞和全因死亡率终点。 主要目的2（安全性目的）：评估AFSW引导的、时间限定的DOAC治疗是否显著 与持续DOAC治疗相比，减少了大出血事件。 假设：随机分配至AFSW指导的时间- 与接受持续DOAC治疗的受试者相比。 探索性目的1：比较两组受试者对抗凝治疗的总体满意度 两个研究手臂。 探索性目的2：比较随机分配至以下研究的受试者的健康相关资源利用估计值： 对照组和实验组