半剂量抗凝与抗血小板治疗减少左心耳闭塞后无症状脑栓塞(HALO-SCE研究):一项随机临床试验的基本原理和设计。

IF 1.5 3区 医学 Q3 CLINICAL NEUROLOGY
Kexin Wang, Linsheng Shi, Zhongbao Ruan, Caiyi Jin, Mingfang Li, Hailei Liu, Hongwu Chen, Weizhu Ju, Minglong Chen
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引用次数: 0

摘要

心房颤动(AF)患者即使在左心房附件(LAA)闭塞后仍面临血栓形成的风险,这可能表现为无症状脑栓塞(SCEs)。半剂量抗凝(Hd-OAC)是一种病理生理上比抗血栓治疗更合理的治疗方法,但仍缺乏强有力的证据。方法:该试验(NCT05671276)是一项多中心、随机对照试验,比较两种抗血栓策略(Hd-OAC治疗与标准抗血栓治疗)对左房附件闭塞(LAAO)后房颤患者的疗效。主要终点是在随访期间进行的任何磁共振成像中新检测到的sce的发生率。次要终点是(1)随访期间发生的两个以上新的sce,其大小和分布,(2)认知功能,(3)全因死亡率,临床血栓栓塞事件和主要出血事件的复合终点。随访时间分别为LAAO后90±15天、180±15天和365±15天。结论:本试验旨在确定与标准抗栓治疗相比,Hd-OAC治疗是否可以降低成功接受LAAO的患者SCE的发生率并保护其认知功能。试验注册:ClinicalTrials.gov: NCT05671276。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Half-Dose Anticoagulation versus Antiplatelet Therapy to Reduce Silent Cerebral Embolism after Left Atrial Appendage Occlusion (HALO-SCE Study): Rationale and Design of a Randomized Clinical Trial.

Introduction: Patients with atrial fibrillation (AF) continue to face thrombotic risks even after the left atrial appendages have been occluded, which may manifest as silent cerebral embolisms (SCEs). Half-dose anticoagulation (Hd-OAC) is a pathophysiologically more reasonable therapy in addressing this issue than antithrombotic therapy, but it still lacks strong evidence.

Methods: The trial (NCT05671276) is a multicenter, randomized controlled trial comparing the efficacy of two antithrombotic strategies (Hd-OAC therapy vs. standard antithrombotic therapy) in AF patients after left atrial appendage occlusion (LAAO). The primary endpoint is the incidence of newly detected SCEs on any magnetic resonance imaging conducted during the follow-up period. The secondary endpoints are: (1) more than two new SCEs during the follow-up, their size, and distribution; (2) cognitive function, and (3) a composite endpoint of all-cause mortality, clinical thromboembolic events, and major bleeding events. Follow-up is scheduled at 90 ± 15 days, 180 ± 15 days, and 365 ± 15 days after LAAO.

Conclusions: This trial aimed to determine whether Hd-OAC therapy can reduce the incidence of SCE and protect cognitive function in patients who have successfully undergone LAAO, compared to standard antithrombotic therapy.

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来源期刊
Cerebrovascular Diseases
Cerebrovascular Diseases 医学-临床神经学
CiteScore
4.50
自引率
0.00%
发文量
90
审稿时长
1 months
期刊介绍: A rapidly-growing field, stroke and cerebrovascular research is unique in that it involves a variety of specialties such as neurology, internal medicine, surgery, radiology, epidemiology, cardiology, hematology, psychology and rehabilitation. ''Cerebrovascular Diseases'' is an international forum which meets the growing need for sophisticated, up-to-date scientific information on clinical data, diagnostic testing, and therapeutic issues, dealing with all aspects of stroke and cerebrovascular diseases. It contains original contributions, reviews of selected topics and clinical investigative studies, recent meeting reports and work-in-progress as well as discussions on controversial issues. All aspects related to clinical advances are considered, while purely experimental work appears if directly relevant to clinical issues.
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