用于预防心房颤动中风的米维仙与阿哌沙班:LIBREXIA 心房颤动试验的原理与设计。

IF 3.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS American heart journal Pub Date : 2024-08-29 DOI:10.1016/j.ahj.2024.08.011
Sneha S. Jain MD, MBA , Kenneth W. Mahaffey MD , Karen S. Pieper MS , Wataru Shimizu MD, PhD , Tatjana Potpara MD, PhD , Christian T. Ruff MD, MPH , Hooman Kamel MD, MS , Basil S. Lewis MD , Jan H. Cornel MD , Peter R. Kowey MD , Jay Horrow MD , John Strony MD , Alexei N. Plotnikov MD , Danshi Li MD, PhD , Stephen Weng PhD , Julia Donahue BA , C. Michael Gibson MS, MD , P. Gabriel Steg MD , Roxana Mehran MD , Jeffrey I. Weitz MD , Carolyn S.P. Lam MBBS, PhD
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引用次数: 0

摘要

背景:直接口服抗凝剂是符合条件的心房颤动和心房扑动患者预防中风的标准治疗方法;然而,出血仍是一个重大问题,限制了其使用。Milvexian 是一种口服因子 XIa 抑制剂,可提供类似的抗凝疗效,但出血风险较低:LIBREXIA AF (NCT05757869)是一项全球性的III期、随机、双盲、平行组、事件驱动试验,旨在比较米维仙与阿哌沙班在心房颤动或心房扑动患者中的疗效。参与者被随机分配到米维仙 100 毫克或阿哌沙班(根据标签说明为 5 毫克或 2.5 毫克),每天两次。主要疗效目标是评估米维仙在预防中风和全身性栓塞方面的效果是否优于阿哌沙班。主要安全性目标是评估米维仙在减少国际血栓与止血学会(ISTH)主要出血事件终点以及ISTH主要和临床相关非主要(CRNM)出血事件复合终点方面是否优于阿哌沙班。计划共招募来自 30 多个国家约 1000 个研究机构的 15500 名参与者。他们将接受随访,直至观察到430例主要疗效结果事件和530例主要安全性事件,预计需要约4年时间:LIBREXIA 心房颤动研究将确定口服因子 XIa 抑制剂米维仙与阿哌沙班相比,对心房颤动或心房扑动患者的疗效和安全性:试验注册:ClinicalTrials.gov NCT05757869。
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Milvexian vs apixaban for stroke prevention in atrial fibrillation: The LIBREXIA atrial fibrillation trial rationale and design

Background

Direct oral anticoagulants are the standard of care for stroke prevention in eligible patients with atrial fibrillation and atrial flutter; however, bleeding remains a significant concern, limiting their use. Milvexian is an oral Factor XIa inhibitor that may offer similar anticoagulant efficacy with less bleeding risk.

Methods

LIBREXIA AF (NCT05757869) is a global phase III, randomized, double-blind, parallel-group, event-driven trial to compare milvexian with apixaban in participants with atrial fibrillation or atrial flutter. Participants are randomly assigned to milvexian 100 mg or apixaban (5 mg or 2.5 mg per label indication) twice daily. The primary efficacy objective is to evaluate if milvexian is noninferior to apixaban for the prevention of stroke and systemic embolism. The principal safety objective is to evaluate if milvexian is superior to apixaban in reducing the endpoint of International Society of Thrombosis and Hemostasis (ISTH) major bleeding events and the composite endpoint of ISTH major and clinically relevant nonmajor (CRNM) bleeding events. In total, 15,500 participants from approximately 1,000 sites in over 30 countries are planned to be enrolled. They will be followed until both 430 primary efficacy outcome events and 530 principal safety events are observed, which is estimated to take approximately 4 years.

Conclusion

The LIBREXIA AF study will determine the efficacy and safety of the oral Factor XIa inhibitor milvexian compared with apixaban in participants with either atrial fibrillation or atrial flutter.

Trial registration

ClinicalTrials.gov NCT05757869

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来源期刊
American heart journal
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.
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