Xanthine oxidase inhibition for the improvement of long-term outcomes following ischaemic stroke and transient ischaemic attack (XILO-FIST) – Protocol for a randomised double blind placebo-controlled clinical trial

Dawson, J. et al. (2018) Xanthine oxidase inhibition for the improvement of long-term outcomes following ischaemic stroke and transient ischaemic attack (XILO-FIST) – Protocol for a randomised double blind placebo-controlled clinical trial. European Stroke Journal, 3(3), pp. 281-290. (doi:10.1177/2396987318771426) (PMID:30246149) (PMCID:PMC6120121)

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Abstract

Background: Allopurinol, a xanthine oxidase inhibitor, reduced progression of carotid-intima media thickness and lowered blood pressure in a small clinical trial in people with ischaemic stroke. Xanthine oxidase inhibition for improvement of long-term outcomes following ischaemic stroke and transient ischaemic attack (XILO-FIST) aims to assess the effect of allopurinol treatment on white matter hyperintensity progression and blood pressure after stroke. This paper describes the XILO-FIST protocol. Methods: XILO-FIST is a multicentre randomised double-blind, placebo-controlled, parallel group clinical trial funded by the British Heart Foundation and the Stroke Association. The trial has been adopted by the Scottish Stroke Research Network and the UK Clinical Research Network. The trial is registered in clinicaltrials.gov (registration number NCT02122718). XILO-FIST will randomise 464 participants, aged greater than 50 years, with ischaemic stroke within the past month, on a 1:1 basis, to two years treatment with allopurinol 300 mg twice daily or placebo. Participants will undergo brain magnetic resonance imaging, cognitive assessment, ambulatory blood pressure monitoring and blood sampling at baseline and after two years treatment. The primary outcome will be white matter hyperintensity progression, measured using the Rotterdam progression scale. Secondary outcomes will include change in white matter hyperintensity volume, mean day-time systolic blood pressure and measures of cognitive function. Up to 100 will undergo additional cardiac magnetic resonance imaging in a sub-study of left ventricular mass. Discussion: If white matter hyperintensity progression is reduced, allopurinol could be an effective preventative treatment for patients with ischaemic stroke and clinical endpoint studies would be needed. If allopurinol reduces blood pressure after stroke, then it could be used to help patients reach blood pressure targets.

Item Type:Articles
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:McConnachie, Dr Alex and Lees, Professor Kennedy and Dickie, Dr David Alexander and Kean, Ms Sharon and Quinn, Dr Terence and Dawson, Professor Jesse and Broomfield, Dr Niall and Dani, Dr Krishna and Muir, Professor Keith and Forbes, Dr Kirsten and Walters, Professor Matthew
Authors: Dawson, J., Broomfield, N., Dani, K., Dickie, D. A., Doney, A., Forbes, K., Houston, G., Kean, S., Lees, K., McConnachie, A., Muir, K. W., Quinn, T., Struthers, A., and Walters, M.
College/School:College of Medical Veterinary and Life Sciences > Institute of Cardiovascular and Medical Sciences
College of Medical Veterinary and Life Sciences > Institute of Health and Wellbeing > Robertson Centre
College of Medical Veterinary and Life Sciences > Institute of Neuroscience and Psychology
College of Medical Veterinary and Life Sciences > School of Medicine, Dentistry & Nursing
Journal Name:European Stroke Journal
Publisher:SAGE Publications
ISSN:2396-9873
ISSN (Online):2396-9881
Published Online:18 April 2018
Copyright Holders:Copyright © 2018 European Stroke Organisation
First Published:First published in European Stroke Journal 3(3): 281-290
Publisher Policy:Reproduced under a Creative Commons License

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Project CodeAward NoProject NamePrincipal InvestigatorFunder's NameFunder RefLead Dept
627381Xanthine oxidase inhibition for improvement of Long-term Outcomes following ischaemic stroke and transient ischaemic attack (XILO-FIST)Jesse DawsonStroke Association (STROKEAS)TSABHF2013/01RI CARDIOVASCULAR & MEDICAL SCIENCES