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ISRCTN
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ISRCTN98638368
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ClinicalTrials.gov identifier
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Public title
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Does allopurinol/urate lowering by xanthine oxidase inhibition have an impact on arterial stiffness in stroke survivors?
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Scientific title
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Acronym
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N/A
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Serial number at source
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Res 02/ A60 2464/02/05
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Study hypothesis
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After the first year of an ischaemic cerebrovascular event (stroke), cardiovascular disease becomes the most common cause of death. A growing body of evidence suggests that serum uric acid is an independent marker of cardiovascular risk. We have shown previously that high urate is associated with cardiac death in 354 stroke survivors who were followed up for a median of 2.8 years, independently of conventional risk factors for atherosclerosis, creatinine and diuretic use.
A larger study by Weir et. al., confirmed these findings and showed that higher serum urate levels, measured on admission to hospital, predicted poor outcome and higher future vascular events after acute stroke.
We sought therefore to determine how uric acid levels correlate with arterial stiffness in those who have cardiovascular disease i.e. stroke survivors. Additionally, several studies have shown that allopurinol improves endothelial function, but its effect on arterial stiffness is not known and finding this out was our second aim.
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Lay summary
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Ethics approval
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Ethical approval for the study was obtained from the local ethics committee (Tayside Medical Ethics Committee, Scotland) and all subjects gave written, informed consent. All study related procedures were conducted according to institutional guidelines and the Declaration of Helsinki.
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Study design
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Randomised, double blinded , placebo controlled study
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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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Stroke
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Participants - inclusion criteria
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Stroke survivors who have a high serum urate
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Participants - exclusion criteria
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1. Documented reaction to allopurinol
2. Persons who were incapable of giving informed consent
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Anticipated start date
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01/02/2002
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Anticipated end date
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01/04/2003
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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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120
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Interventions
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Patients were randomly allocated to receive either allopurinol 300 mg once daily or matched placebo. Baseline measurements were taken as part of the initial study and follow-up measurements were made after eight weeks of treatment.
Patients attended for one additional visit at two weeks, non-fasted, for measurements of urea and electrolytes, liver function testing, and for monitoring of any adverse reactions.
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Primary outcome measure(s)
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Correlation between arterial stiffness and urate levels.
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Secondary outcome measure(s)
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Effect of allopurinol on arterial stiffness.
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Sources of funding
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1. Chest Heart and Stroke Scotland (Grant Ref: Res 02/ A60)
2. Heart Research UK (Grant Ref 2464/02/05)
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Trial website
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Publications
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1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/19035875
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Contact name
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Dr
Faisel
Khan
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Address
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Department of Vascular Medicine
Level 7
Ninewells Hospital
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City/town
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Dundee
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Zip/Postcode
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DD1 9SY
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Country
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United Kingdom
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Tel
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+44 (0)1382 635574
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Email
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f.khan@dundee.ac.uk
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Sponsor
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University of Dundee (UK)
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Address
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Nethergate
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City/town
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Dundee
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Zip/Postcode
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DD1 4HN
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Country
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United Kingdom
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Tel
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+44 (0)1382 660111 ext 33450
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Fax
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+44 (0)1382 644972
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Email
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j.george@dundee.ac.uk
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Sponsor website:
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http://www.dundee.ac.uk
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Date applied
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29/11/2006
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Last edited
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24/03/2011
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Date ISRCTN assigned
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13/12/2006
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