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ISRCTN
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ISRCTN26156392
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DOI
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10.1186/ISRCTN26156392
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Asymptomatic Carotid Surgery Trial
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Scientific title
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Acronym
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ACST
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Serial number at source
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G9408332
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Study hypothesis
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The aim is to determine whether CEA and BMT improve stroke-free survival time when compared to BMT alone. The trial will also help identify high-risk groups in whom the benefits of surgery and of BMT would be increased
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Carotid stenosis
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Participants - inclusion criteria
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Patients whose carotid stenosis has not caused symptoms for at least 6 months, who have no past history of ipsilateral disabling or severe contralateral stroke and have no clear indications or contraindications to carotid endarterectomy (CEA)
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Participants - exclusion criteria
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1. Patients with a small likelihood of worthwhile benefit e.g. those with major life-threatening disease.
2. Patients who have had recent myocardial infarct, intracerebral neoplasia or aneurysm, or restenosis of an artery following previous CEA
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Anticipated start date
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01/04/1993
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Anticipated end date
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31/03/2004
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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3120
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Interventions
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CEA and best medical treatment (BMT) vs BMT alone
Added 19/08/08: follow-up is minimum of 5 years
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Primary outcome measure(s)
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Fatal and non-fatal stroke and death rates in medical treatment and surgery group versus medical treatment alone
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Secondary outcome measure(s)
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Subsidiary analyses in an effort to identify high and low risk groups will include the effect of risk factors such as presence or absence of silent cerebral infarction on clinical outcome
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Sources of funding
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Medical Research Council (MRC) (UK)
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Trial website
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http://www.acst.org.uk/acst-1_results/index.php
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Publications
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1. 2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15135594
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20870099
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Contact name
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Miss
Alison
Halliday
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Address
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ACST, Department of Cardiological Sciences
St George's Hospital Medical School
Cranmer Terrace
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City/town
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London
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Zip/Postcode
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SW17 0RE
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Country
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United Kingdom
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Email
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Sponsor
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Medical Research Council (MRC) (UK)
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Address
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20 Park Crescent
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City/town
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London
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Zip/Postcode
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W1B 1AL
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 5422
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Fax
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+44 (0)20 7436 6179
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Email
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clinical.trial@headoffice.mrc.ac.uk
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Sponsor website:
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http://www.mrc.ac.uk
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Date applied
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23/10/2000
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Last edited
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27/10/2010
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Date ISRCTN assigned
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23/10/2000
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