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 | |
发表日期 | 2010-05 |
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 |
页数 | 9 |
WOS类目 | Clinical Neurology |
WOS研究方向 | Neurosciences & Neurology |
WOS记录号 | WOS:000277384600013 |
收录类别 | SCIE ; SCOPUS |
URL | 查看原文 |
PubMed ID | 2033507 |
SCOPUSEID | 2-s2.0-77950627212 |
自科自定义期刊分类 | T2(A)类 |
通讯作者地址 | [Wong, Ka Sing Lawrence]Departments of Medicine and Therapeutics,Chinese University of Hong Kong,Hong Kong |
Scopus学科分类 | Neurology (clinical) |
TOP期刊 | TOP期刊 |
引用统计 | |
文献类型 | 期刊论文 |
条目标识符 | https://kms.wmu.edu.cn/handle/3ETUA0LF/20666 |
专题 | 第一临床医学院(信息与工程学院)、附属第一医院 附属第一医院 |
通讯作者 | Wong, Ka Sing Lawrence |
作者单位 | 1.Departments of Medicine and Therapeutics,Chinese University of Hong Kong,Hong Kong; 2.Department of Pharmacology,National University of Singapore,Singapore; 3.Shanghai Huashan Hospital,China; 4.Department of Neurology,Singapore General Hospital,Singapore; 5.Chulalongkorn University Hospital,Thailand; 6.Peking University First Hospital,China; 7.The First Affiliated Hospital,Wenzhou Medical College,China; 8.University Malaya Medical Centre,Malaysia; 9.Ramathibodi Hospital,Thailand; 10.Singapore Clinical Research Institute,Singapore; 11.Department of Clinical Neuroscience,St George's,University of London,United Kingdom |
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. |
条目包含的文件 | 条目无相关文件。 |
除非特别说明,本系统中所有内容都受版权保护,并保留所有权利。
修改评论