Comparison of clopidogrel-based antiplatelet therapy versus warfarin as a secondary prevention strategy for AntiPhospholipid Syndrome-related STROKE (APS-STROKE): Rationale and design of a prospective, randomized, open-label, blinded-endpoint trial

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2026-01-01 Epub Date: 2025-11-25 DOI:10.1016/j.cct.2025.108164

Wookjin Yang , Hee-Kwon Park , Seong-Ho Koh , Seongheon Kim , Yerim Kim , Keun-Hwa Jung , Hyun Goo Kang , Jay Chol Choi , Hahn Young Kim , Hyo Suk Nam , Hye Seon Jeong , Joon-Tae Kim , Young Seo Kim , Sungwook Yu , Kyung-Hee Cho , Tae-Jin Song , Sung Hyuk Heo , Han-Jin Cho , Sung-Il Sohn , Yoonkyung Chang , Seung-Hoon Lee

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引用次数: 0

Abstract

Background

Antiphospholipid syndrome (APS) is closely associated with ischemic stroke. However, optimal treatment for APS-related stroke remains unestablished, as current guidelines are based on outdated studies and expert opinion rather than high-quality clinical trials. Evidence on antiplatelet agents other than aspirin, such as clopidogrel, in APS-related stroke is particularly limited. Given the relatively young age of patients with APS and the burden of warfarin use, verifying its necessity is crucial. This study compares clopidogrel-based antiplatelet therapy and warfarin for secondary prevention in APS-related stroke.

Methods

APS-STROKE is an exploratory, multicenter, prospective, randomized, open, blinded-endpoint clinical trial. Adult patients with definite APS and a history of ischemic stroke or transient ischemic attack (TIA) will be included. Patients with high-risk APS (triple positivity or persistently high titers of anti-cardiolipin or anti-β2-glycoprotein I antibodies), systemic lupus erythematosus, or other major indications for continued antiplatelet or anticoagulant therapy will be excluded. Participants will be randomized 1:1 to receive clopidogrel-based antiplatelet therapy or warfarin. More than 200 patients are planned for inclusion across 32 stroke centers. The primary endpoint is a composite of any death, major adverse cardiovascular events, systemic thromboembolic events, and major bleeding during at least 4 years of follow-up. Secondary endpoints include major adverse cardiovascular events, ischemic stroke, any bleeding, major bleeding, intracranial bleeding, clinically relevant non-major bleeding, any death, and thrombosis-related death.

Conclusion

This study will provide valuable information on the optimal secondary prevention strategy for APS-related stroke.

Trial registration

ClinicalTrials.gov: NCT05995600; CRIS: KCT0008900.

查看原文本刊更多论文

基于氯吡格雷的抗血小板治疗与华法林作为抗磷脂综合征相关卒中（mps -STROKE）二级预防策略的比较：一项前瞻性、随机、开放标签、盲终点试验的基本原理和设计

背景：抗磷脂综合征（APS）与缺血性脑卒中密切相关。然而，由于目前的指南是基于过时的研究和专家意见，而不是高质量的临床试验，aps相关卒中的最佳治疗方法仍未确定。除阿司匹林以外的抗血小板药物（如氯吡格雷）在aps相关卒中中的应用证据尤其有限。考虑到APS患者的年龄相对较轻和使用华法林的负担，验证其必要性至关重要。本研究比较了基于氯吡格雷的抗血小板治疗和华法林在aps相关卒中二级预防中的作用。方法：APS-STROKE是一项探索性、多中心、前瞻性、随机、开放、盲终点的临床试验。有明确APS和缺血性卒中或短暂性脑缺血发作（TIA）病史的成年患者将被纳入研究范围。高危APS（抗心磷脂或抗β2-糖蛋白I抗体三重阳性或持续高滴度）、系统性红斑狼疮或其他需要持续抗血小板或抗凝治疗的主要适应症患者将被排除在外。参与者将以1:1的比例随机接受基于氯吡格雷的抗血小板治疗或华法林。计划纳入32个中风中心的200多名患者。主要终点是至少4 年随访期间的任何死亡、主要不良心血管事件、全身性血栓栓塞事件和主要出血的综合指标。次要终点包括主要不良心血管事件、缺血性卒中、任何出血、大出血、颅内出血、临床相关的非大出血、任何死亡和血栓相关死亡。结论：本研究将为aps相关卒中的最佳二级预防策略提供有价值的信息。试验注册：ClinicalTrials.gov: NCT05995600；克里斯:KCT0008900。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.