Clopidogrel plus aspirin versus aspirin alone for reducing embolisation in patients with acute symptomatic cerebral or carotid artery stenosis (CLAIR study): a randomised, open-label, blinded-endpoint trial

doi:10.1016/S1474-4422(10)70060-0

科研成果详情

题名	Clopidogrel plus aspirin versus aspirin alone for reducing embolisation in patients with acute symptomatic cerebral or carotid artery stenosis (CLAIR study): a randomised, open-label, blinded-endpoint trial
作者	Wong, Ka Sing Lawrence 1,2; Chen, Christopher 3; Fu, Jianhui 4; Chang, Hui Meng 5; Suwanwela, Nijasri C.6; Huang, Yining N.7; Han, Zhao8; Tan, Kay Sin 9; Ratanakorn, Disya 10; Chollate, Pavithra 11; Zhao, Yudong 11; Koh, Angeline 11; Hao, Qing 1,2; Markus, Hugh S.12
发表期刊	LANCET NEUROLOGY 影响因子和分区
语种	英语
原始文献类型	Article
其他关键词	TRANSIENT ISCHEMIC ATTACK ; DUAL ANTIPLATELET THERAPY ; PLACEBO-CONTROLLED TRIAL ; DOPPLER EMBOLIC SIGNALS ; S-NITROSOGLUTATHIONE ; OCCLUSIVE DISEASE ; STROKE RISK ; ASYMPTOMATIC EMBOLIZATION ; MICROEMBOLIC SIGNALS ; RECURRENCE
摘要	Background Few randomised clinical trials have investigated the use of antithrombotic drugs for early secondary prevention of stroke or transient ischaemic attack in patients with intracranial atherosclerotic stenosis. Microembolic signals, detected by transcranial doppler, are a surrogate marker of future stroke risk and have been used to show treatment efficacy in patients with extracranial carotid stenosis. We aimed to investigate whether treatment with clopidogrel plus aspirin reduced the number of microembolic signals detected with transcranial doppler ultrasound compared with aspirin alone in patients with recent stroke. Methods The clopidogrel plus aspirin for infarction reduction in acute stroke or transient ischaemic attack patients with large artery stenosis and microembolic signals (CLAIR) trial was a randomised, open-label, blinded-endpoint trial. Between Oct 28,2003, and Nov 19,2008, patients with acute ischaemic stroke or transient ischaemic attack who had symptomatic large artery stenosis in the cerebral or carotid arteries and in whom microembolic signals were present on transcranial doppler were randomly assigned within 7 days of symptom onset to receive clopidogrel (300 mg for the first day, then 75 mg daily) plus aspirin (75-160 mg daily) or aspirin alone (75-160 mg daily) for 7 days. Patients were randomly assigned in blocks of four or six by use of a randomisation website. Monitoring of microembolic signals on transcranial doppler was done on days 2 and 7. The primary endpoint was the proportion of patients who had microembolic signals on day 2. Analysis was by modified intention to treat. All analyses were done by an investigator masked to both patient identity and the day the recording was taken. This trial is registered with the Centre for Clinical Trials, Chinese University of Hong Kong, number CUHK_CCT00164. Findings 100 patients were randomly assigned to clopidogrel plus aspirin (n=47) or aspirin monotherapy (n=53). 93 of 100 patients had symptomatic intracranial stenosis in either the intracranial internal carotid artery or the middle cerebral artery: 45 of 46 in the dual therapy group and 48 of 52 in the monotherapy group. At day 2,14 of 45 patients in the dual therapy group and 27 of 50 patients in the monotherapy group for whom data were available had at least one microembolic signal on transcranial doppler (relative risk reduction 42.4%, 95% CI 4.6-65.2; p=0.025). Adverse events were similar in the two groups. No patients had intracranial or severe systemic haemorrhage, but two patients in the dual therapy group had minor haemorrhages. Interpretation Combination therapy with clopidogrel and aspirin is more effective than aspirin alone in reducing microembolic signals in patients with predominantly intracranial symptomatic stenosis. Clinical trials are now warranted to investigate whether this combination treatment also results in a reduction in stroke incidence.
资助项目	Boehringer IngelheimBoehringer Ingelheim; OtsukaOtsuka Pharmaceutical; Sanofi-AventisSanofi-Aventis; ServierServier; PfizerPfizer; TakedaTakeda Pharmaceutical Company Ltd; AstraZenecaAstraZeneca; Chinese University of Hong KongChinese University of Hong Kong; Research Grant CouncilHong Kong Research Grants Council [CUHK4440/03M]; Singapore Clinical Research Institute, Singapore
出版者	ELSEVIER SCIENCE INC
出版地	NEW YORK
ISSN	1474-4422
EISSN	1474-4465
卷号	9 期号:5 页码:489-497
DOI	10.1016/S1474-4422(10)70060-0
WOS类目	Clinical Neurology
WOS研究方向	Neurosciences & Neurology
WOS记录号	WOS:000277384600013
收录类别	SCIE ; SCOPUS
发表日期	2010-05
URL	查看原文
Scopus记录号	2-s2.0-77950627212
自科自定义期刊分类	T2(A)类
引用统计	被引频次：276[WOS] [WOS记录] [WOS相关记录]
文献类型	期刊论文
条目标识符	https://kms.wmu.edu.cn/handle/3ETUA0LF/20666
专题	附属第一医院
通讯作者	Wong, Ka Sing Lawrence
作者单位	1.Chinese Univ Hong Kong, Dept Med, Hong Kong, Hong Kong, Peoples R China; 2.Chinese Univ Hong Kong, Dept Therapeut, Hong Kong, Hong Kong, Peoples R China; 3.Natl Univ Singapore, Dept Pharmacol, Singapore 117597, Singapore; 4.Shanghai Huashan Hosp, Shanghai, Peoples R China; 5.Singapore Gen Hosp, Dept Neurol, Singapore 0316, Singapore; 6.Chulalongkorn Univ Hosp, Bangkok, Thailand; 7.Peking Univ, Hosp 1, Beijing 100871, Peoples R China; 8.Wenzhou Med Coll, Affiliated Hosp 1, Wenzhou, Peoples R China; 9.Univ Malaya, Med Ctr, Kuala Lumpur, Malaysia; 10.Ramathibodi Hosp, Bangkok, Thailand; 11.Singapore Clin Res Inst, Singapore, Singapore; 12.Univ London, Dept Clin Neurosci, London, England
推荐引用方式 GB/T 7714	Wong, Ka Sing Lawrence,Chen, Christopher,Fu, Jianhui,et al. Clopidogrel plus aspirin versus aspirin alone for reducing embolisation in patients with acute symptomatic cerebral or carotid artery stenosis (CLAIR study): a randomised, open-label, blinded-endpoint trial[J]. LANCET NEUROLOGY,2010,9(5):489-497.
APA	Wong, Ka Sing Lawrence., Chen, Christopher., Fu, Jianhui., Chang, Hui Meng., Suwanwela, Nijasri C.., ... & Markus, Hugh S.. (2010). Clopidogrel plus aspirin versus aspirin alone for reducing embolisation in patients with acute symptomatic cerebral or carotid artery stenosis (CLAIR study): a randomised, open-label, blinded-endpoint trial. LANCET NEUROLOGY, 9(5), 489-497.
MLA	Wong, Ka Sing Lawrence,et al."Clopidogrel plus aspirin versus aspirin alone for reducing embolisation in patients with acute symptomatic cerebral or carotid artery stenosis (CLAIR study): a randomised, open-label, blinded-endpoint trial".LANCET NEUROLOGY 9.5(2010):489-497.