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ISRCTN
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ISRCTN19313375
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DOI
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10.1186/ISRCTN19313375
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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A randomised controlled trial of patient self management of oral anticoagulation compared to standard care
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Scientific title
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Acronym
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SMART: Self-Management of Anticoagulation, a Randomised Trial
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Serial number at source
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G9900263
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Study hypothesis
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The null hypothesis is that patients managing their own anticoagulation can achieve as good therapeutic control as patients receiving standard care.
Please note that as of 07/02/2007 this record was updated to include the current target number of participants. The previous target number of participants at the time of registration was 660.
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Lay summary
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Not provided at time of registration
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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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Anticoagulant therapy
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Participants - inclusion criteria
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All patients aged over 18 receiving warfarin therapy
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/09/2000
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Anticipated end date
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30/06/2003
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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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512
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Interventions
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The intervention comprises a training programme to enable patients to undertake oral anticoagulation monitoring at home.
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Primary outcome measure(s)
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1. Therapeutic international normalised ratio (INR) control
2. Bleeding and thrombotic complications
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Medical Research Council (UK)
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Trial website
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Publications
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1. 2003 protocol in http://www.ncbi.nlm.nih.gov/pubmed/13678426
2. 2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16216821
3. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21068191
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Contact name
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Mr
A
Fitzmaurice
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Address
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The Department of Primary Care and General Practice
The Medical School
The University of Birmingham
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City/town
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Birmingham
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Zip/Postcode
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B15 2TT
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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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21/07/2011
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Date ISRCTN assigned
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23/10/2000
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