低剂量利伐沙班口服抗凝治疗老年房颤患者的疗效和安全性：多中心随机对照试验（SAFE-AF）的基本原理、设计和研究方案

IF 3.5 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

American heart journal Pub Date : 2025-07-15 DOI:10.1016/j.ahj.2025.07.011

Jiawei Han MD , Wenwei Qi MD , Shuo Yuan MD , Hanning Liu MD, PhD , Yang Wang PhD , Heng Zhang MD, PhD , Jiamin Liu MD , Yan Zhao MD , Yue Zhang MD , Lihui Zheng MD, PhD , Yan Yao MD, PhD , Zhe Zheng MD, PhD

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引用次数: 0

摘要

背景：非维生素K拮抗剂（NOAC）被认为是房颤（AF）患者降低卒中风险的一线治疗方法，尤其是在老年人中。然而，关于低剂量NOAC的适宜性，缺乏强有力的临床证据。设计：SAFE-AF试验是一项研究者发起的、多中心、开放标签、随机对照、盲终点评价、非效性设计的试验，比较低剂量利伐沙班和标准剂量利伐沙班对≥70岁AF患者的疗效和安全性。参与者（N = 4374）将按1:1的比例随机分配，接受标准剂量利伐沙班（20mg每日一次）或低剂量利伐沙班（15mg每日一次）。主要疗效终点是临床事件的复合终点，包括心血管死亡、心肌梗死、中风和全身栓塞事件（SEE）。主要安全终点是大出血事件和临床相关的非大出血事件的复合终点。结论：SAFE-AF试验旨在为低剂量利伐沙班用于老年af患者抗凝治疗提供有效证据。试验注册：ClinicalTrials.gov，标识号NCT06108414。

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Efficacy and safety of low-dose rivaroxaban in elderly patients with atrial fibrillation for oral anticoagulation therapy: Rationale, design, and study protocol for a multicenter randomized controlled trial (SAFE-AF)

Background

Non–vitamin K antagonist anticoagulant (NOAC) is considered the first-line treatment for atrial fibrillation (AF) patients to reduce the risk of stroke, especially in the elderly. However, robust clinical evidence is lacking regarding the appropriateness of low-dose NOAC.

Design

The SAFE-AF trial is an investigator-initiated, multicenter, open-label, randomized controlled, blind endpoint evaluation, non-inferiority designed trial comparing the efficacy and safety of low-dose rivaroxaban with standard-dose rivaroxaban in patients aged ≥70 years with AF. Participants (N = 4,374) will be randomized 1:1 to receive either standard-dose rivaroxaban (20 mg once daily) or low-dose rivaroxaban (15 mg once daily). The primary efficacy endpoint is the composite endpoint of clinical events including cardiovascular death, myocardial infarction, stroke, and systemic embolic events (SEE). The primary safety endpoint is the composite endpoint of major bleeding events and clinically relevant non-major bleeding events.

Conclusions

The SAFE-AF trial is intended to provide valid evidence concerning low-dose rivaroxaban for anticoagulant therapy in older patients with AF.

Trial registration

ClinicalTrials.gov, identifier NCT06108414.

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来源期刊

American heart journal 医学-心血管系统

CiteScore

8.20

自引率

2.10%

发文量

214

审稿时长

38 days

期刊介绍： The American Heart Journal will consider for publication suitable articles on topics pertaining to the broad discipline of cardiovascular disease. Our goal is to provide the reader primary investigation, scholarly review, and opinion concerning the practice of cardiovascular medicine. We especially encourage submission of 3 types of reports that are not frequently seen in cardiovascular journals: negative clinical studies, reports on study designs, and studies involving the organization of medical care. The Journal does not accept individual case reports or original articles involving bench laboratory or animal research.