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: 10509310
• 负责人: ROD S PASSMAN
• 金额: $ 361.01万
• 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 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10509310
• 关键词: Anticoagulants; Anticoagulation; Area; Arrhythmia; Atrial Fibrillation; Benefits and Risks; Blinded; Blood Cells; Caring; Chronic; Clinical; Clinical Trials; Compartment syndromes; Elements; Embolism; Erythrocytes; Evaluation; Event; Exposure to; Goals; Health; Health Care Costs; Hemoglobin concentration result; Hemorrhage; Hemostatic function; Hour; International; Intramuscular; Ischemic Stroke; Monitor; Oral; Organ; Outcome; Participant; Patients; Pericardial body location; Phase; Quality of life; Randomized; Recording of previous events; Resources; Retroperitoneal Space; Risk; Safety; Sinus; Societies; Stroke; Stroke prevention; Testing; Therapeutic; Thrombosis; Time; Transfusion; Vision; Whole Blood; base; comparative efficacy; cost; design; evidence base; experimental arm; falls; health care service utilization; high risk; improved; innovation; mortality; new technology; novel; novel strategies; open label; precision medicine; prospective; response; satisfaction; smart watch; standard of care; stroke risk; treatment strategy; trial comparing; two-arm study; wearable device

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.

项目摘要 /摘要 目的：通过连续监测房颤的抗凝节奏评估（反应） AF）临床试验将比较两种治疗策略的预防中风的效率和安全性 纤颤（AF）：当前连续直接口服抗凝（DOAC）与新型策略的当前标准 精度，时间限制的DOAC仅是针对AF传感器检测到的≥1小时AF发作的 智能手表（AFSW（Apple Watch））。 理由：中风风险通常与AF发作和持续时间暂时相关，但出血风险仍在继续 即使在漫长的无AF时期中风风险可能较低的情况下，抗凝暴露的恒定风险也是如此。反应 - AF将评估长时间窦性节奏期间扣留抗凝抗凝的益处和风险 在AFSW的指导下。与连续的DOAC相比，AFSW引导，时间限制的DOAC治疗可能 在维持中风保护的同时，减少出血事件。这有可能改善重要的主要临床 结果和生活质量，同时降低医疗保健利用。 设计：React-AF是一个多中心的前瞻性，随机，开放标签，盲目端点（探针设计）试验 比较连续DOAC给药与时间限制的DOAC的当前护理标准 由AFSW指导的治疗阵发或持续的AF且低至中度的患者 中风风险（CHA2DS2-VASC得分为1-4）。这项研究将具有初始剥夺阶段的第一阶段 具有务实元素的II期。 主要目的1（疗效目标）：评估AFSW引导的，时间推迟的DOAC治疗是否不是 - 用于复合终点的连续DOAC治疗，包括：（1）缺血性中风； （2）系统性 栓塞; （3）全因死亡率。 假设：时间限制的DOAC疗法对复合材料的连续DOAC治疗不属于 缺血性中风，全身栓塞和全因死亡率的终点。 主要目的2（安全目标）：评估AFSW引导，时间限制的DOAC治疗是否显着 与连续的DOAC治疗相比，减少了主要的出血事件。 假设：随机分配给AFSW引导，时间 - 与接受DOAC持续治疗的参与者相比，DOAC治疗的定界疗法。 探索目的1：比较总体参与满意度与抗凝管理 两个研究臂。 探索目的2：比较随机的参与者中与健康相关资源利用的估计值 控制与实验臂。