{"title":"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。","authors":"Kexin Wang, Linsheng Shi, Zhongbao Ruan, Caiyi Jin, Mingfang Li, Hailei Liu, Hongwu Chen, Weizhu Ju, Minglong Chen","doi":"10.1159/000547304","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":9683,"journal":{"name":"Cerebrovascular Diseases","volume":" ","pages":"1-6"},"PeriodicalIF":1.5000,"publicationDate":"2025-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"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.\",\"authors\":\"Kexin Wang, Linsheng Shi, Zhongbao Ruan, Caiyi Jin, Mingfang Li, Hailei Liu, Hongwu Chen, Weizhu Ju, Minglong Chen\",\"doi\":\"10.1159/000547304\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>\",\"PeriodicalId\":9683,\"journal\":{\"name\":\"Cerebrovascular Diseases\",\"volume\":\" \",\"pages\":\"1-6\"},\"PeriodicalIF\":1.5000,\"publicationDate\":\"2025-07-15\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Cerebrovascular Diseases\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1159/000547304\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"CLINICAL NEUROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Cerebrovascular Diseases","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1159/000547304","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}
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.
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.