IR@PKUHSC  > 北京大学第一临床医学院
学科主题临床医学
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
Wong, Ka Sing Lawrence1,2; Chen, Christopher3; Fu, Jianhui4; Chang, Hui Meng5; Suwanwela, Nijasri C.6; Huang, Yining N.7; Han, Zhao8; Tan, Kay Sin9; Ratanakorn, Disya10; Chollate, Pavithra11; Zhao, Yudong11; Koh, Angeline11; Hao, Qing1,2; Markus, Hugh S.12; CLAIR Study Invest
刊名LANCET NEUROLOGY
2010-05-01
DOI10.1016/S1474-4422(10)70060-0
9期:5页:489-497
收录类别SCI
文章类型Article
WOS标题词Science & Technology
类目[WOS]Clinical Neurology
资助者Boehringer Ingelheim ; Otsuka ; Sanofi-Aventis ; Servier ; Pfizer ; Takeda ; AstraZeneca ; Chinese University of Hong Kong ; Research Grant Council ; Singapore Clinical Research Institute, Singapore ; Boehringer Ingelheim ; Otsuka ; Sanofi-Aventis ; Servier ; Pfizer ; Takeda ; AstraZeneca ; Chinese University of Hong Kong ; Research Grant Council ; Singapore Clinical Research Institute, Singapore
研究领域[WOS]Neurosciences & Neurology
关键词[WOS]TRANSIENT ISCHEMIC ATTACK ; DUAL ANTIPLATELET THERAPY ; PLACEBO-CONTROLLED TRIAL ; DOPPLER EMBOLIC SIGNALS ; S-NITROSOGLUTATHIONE ; OCCLUSIVE DISEASE ; STROKE RISK ; ASYMPTOMATIC EMBOLIZATION ; MICROEMBOLIC SIGNALS ; RECURRENCE
英文摘要

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.

语种英语
所属项目编号CUHK4440/03M
资助者Boehringer Ingelheim ; Otsuka ; Sanofi-Aventis ; Servier ; Pfizer ; Takeda ; AstraZeneca ; Chinese University of Hong Kong ; Research Grant Council ; Singapore Clinical Research Institute, Singapore ; Boehringer Ingelheim ; Otsuka ; Sanofi-Aventis ; Servier ; Pfizer ; Takeda ; AstraZeneca ; Chinese University of Hong Kong ; Research Grant Council ; Singapore Clinical Research Institute, Singapore
WOS记录号WOS:000277384600013
Citation statistics
Cited Times:160[WOS]   [WOS Record]     [Related Records in WOS]
文献类型期刊论文
条目标识符http://ir.bjmu.edu.cn/handle/400002259/56470
Collection北京大学第一临床医学院
作者单位1.Shanghai Huashan Hosp, Shanghai, Peoples R China
2.Singapore Gen Hosp, Dept Neurol, Singapore 0316, Singapore
3.Chulalongkorn Univ Hosp, Bangkok, Thailand
4.Peking Univ, Hosp 1, Beijing 100871, Peoples R China
5.Univ London, Dept Clin Neurosci, London, England
6.Univ Malaya, Med Ctr, Kuala Lumpur, Malaysia
7.Ramathibodi Hosp, Bangkok, Thailand
8.Singapore Clin Res Inst, Singapore, Singapore
9.Chinese Univ Hong Kong, Dept Med, Hong Kong, Hong Kong, Peoples R China
10.Chinese Univ Hong Kong, Dept Therapeut, Hong Kong, Hong Kong, Peoples R China
11.Natl Univ Singapore, Dept Pharmacol, Singapore 117597, Singapore
12.Wenzhou Med Coll, Affiliated Hosp 1, Wenzhou, Peoples R China
Recommended Citation
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..,...&CLAIR Study Invest.(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.
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