XILO-FIST, the Effect of Allopurinol on the Brain Heart and Blood Pressure After Stroke
XILO-FIST
Xanthine Oxidase Inhibition for Improvement of Long-term Outcomes Following Ischaemic Stroke and Transient Ischaemic Attack
2 other identifiers
interventional
464
1 country
21
Brief Summary
Recurrent stroke and cognitive decline are common after ischaemic stroke. Allopurinol, a drug usually used to treat gout, has been shown to reduce heart ischaemia, heart size, and arterial stiffness and to relax brain blood vessels and may reduce the blood pressure. All of these properties may be associated with a lower risk of second stroke and cognitive decline. We now aim to explore whether allopurinol will reduce further damage to the brain (called white matter hyper-intensities) after stroke and also whether it reduces heart size and blood pressure after stroke. We will conduct a multi-centre randomised, double-blind placebo controlled study to investigate whether two years allopurinol 300 mg twice per day (BD) improves these 3 outcomes, which are inextricably linked to risk of recurrence and cognitive decline after ischaemic stroke.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2014
Longer than P75 for phase_4
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 23, 2014
CompletedFirst Posted
Study publicly available on registry
April 24, 2014
CompletedStudy Start
First participant enrolled
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2021
CompletedNovember 12, 2021
November 1, 2021
6.8 years
April 23, 2014
November 11, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
White matter hyper-intensities (WMH) progression rate over 2 years, defined using the Rotterdam Progression Score
2 years
Secondary Outcomes (18)
change in mean day-time systolic BP at 1 month
1 month
change in mean day-time diastolic BP at 1 month
1 month
Schmidt's Progression Score
2 years
Fazekas score
2 years
Scheltens scale score
2 years
- +13 more secondary outcomes
Other Outcomes (6)
Cardiac sub-study: Change in measured Left ventricular mass (LVM) at 2 years
2 years
Cardiac sub-study: change in ejection fraction
2 years
Cardiac Sub-study: change in end diastolic volume
2 years
- +3 more other outcomes
Study Arms (2)
Allopurinol
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Ischaemic Stroke/ Ischaemic lesion on brain imaging in relevant anatomical territory in patients with transient ischaemic attack.
- Age greater than 50 years. -- Consent within one month of stroke.
You may not qualify if:
- Modified Rankin scale score of 5 (at end of the possible enrolment window of one month after stroke).
- Diagnosis of dementia (defined as a documented diagnosis or a screening Informant Questionnaire for Cognitive Decline in the Elderly (IQCODE) score of 3.6 or more).
- Cognitive impairment deemed sufficient to compromise capacity to consent or to comply with the protocol (in the opinion of the local investigator).
- Dependent on daily help from others for basic or instrumental activities of daily living prior to stroke (defined as assistance needed with toileting, walking or dressing).
- Significant co-morbidity or frailty likely to cause death within 24 months or likely to make adherence to study protocol difficult for participant (in the opinion of the local investigator).
- Contra-indication to or indication for administration of allopurinol (as detailed in Summary of Product Characteristics on the XILO-FIST web portal and in trial master file).
- Concurrent azathioprine, 6-mercaptopurine therapy, other cytotoxic therapies, cyclosporin, theophylline and didanosine.
- Significant hepatic impairment (defined as serum bilirubin, Aspartate Aminotransferase (AST) or Alanine transaminase (ALT) greater than three times upper limit of normal (ULN)).
- Estimated Glomerular Filtration Rate \< 30 mls/min
- Contraindication to MRI scanning.
- Women who are pregnant or breastfeeding.
- Women of childbearing potential who are unable or unwilling to use contraception.
- Prisoners.
- Active participation in another Clinical Trial of Investigational Medicinal Product (CTIMP) or device trial or participation within the past month.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NHS Greater Glasgow and Clydelead
- University of Glasgowcollaborator
Study Sites (21)
Altnagelvin Campus
Londonderry, County Derry, BT47 6SB, United Kingdom
Broomfield Hospital
Chelmsford, Essex, CM1 7ET, United Kingdom
Southend University Hospital
Westcliff-on-Sea, Essex, SS0 0RY, United Kingdom
Darent Valley Hospital
Dartford, Kent, DA2 8DA, United Kingdom
The Royal London Hospital
Whitechapel, London, E1 1BB, United Kingdom
Northumbria NHS Trust
Ashington, Northumberland, NE63 9JJ, United Kingdom
Royal United Hospital
Bath, Somerset, BA1 3NG, United Kingdom
Royal Stoke University Hosptial
Stoke-on-Trent, Staffordshire, ST4 6QG, United Kingdom
NHS Grampian
Aberdeen, AB25 2ZD, United Kingdom
NHS Lanarkshire
Airdrie, ML6 0JS, United Kingdom
NHS Tayside
Dundee, DD1 9SY, United Kingdom
South West Acute Hospital
Enniskillen, BT74 6DN, United Kingdom
NHS Greater Glagsow and Clyde
Glasgow, G11 6NT, United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, LS1 3EX, United Kingdom
Barnet Hospital
London, EN5 3DJ, United Kingdom
Guys and St Thomas NHS Foundation Trust
London, SE1 7EH, United Kingdom
UCL Stroke Research Centre
London, WC1B 5EH, United Kingdom
Luton and Dunstable University Hosptial
Luton, LU4 0DZ, United Kingdom
Newcastle UPon Tyne Hospitals NHS Trust
Newcastle, NE2 4AB, United Kingdom
Nottingham University
Nottingham, NG5 1PB, United Kingdom
City Hospital Sunderland NHS Foundation Trust
Sunderland, SR4 7TP, United Kingdom
Related Publications (2)
Dawson J, Robertson M, Dickie DA, Bath P, Forbes K, Quinn T, Broomfield NM, Dani K, Doney A, Houston G, Lees KR, Muir KW, Struthers A, Walters M, Barber M, Bhalla A, Cameron A, Dyker A, Guyler P, Hassan A, Kearney MT, Keegan B, Lakshmanan S, Macleod MJ, Randall M, Shaw L, Subramanian G, Werring D, McConnachie A. Xanthine oxidase inhibition and white matter hyperintensity progression following ischaemic stroke and transient ischaemic attack (XILO-FIST): a multicentre, double-blinded, randomised, placebo-controlled trial. EClinicalMedicine. 2023 Feb 16;57:101863. doi: 10.1016/j.eclinm.2023.101863. eCollection 2023 Mar.
PMID: 36864979DERIVEDDawson J, Broomfield N, Dani K, Dickie DA, Doney A, Forbes K, Houston G, Kean S, Lees K, McConnachie A, Muir KW, Quinn T, Struthers A, Walters M. 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. Eur Stroke J. 2018 Sep;3(3):281-290. doi: 10.1177/2396987318771426. Epub 2018 Apr 18.
PMID: 30246149DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jesse Dawson
University of Glasgow
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2014
First Posted
April 24, 2014
Study Start
May 1, 2014
Primary Completion
February 1, 2021
Study Completion
February 1, 2021
Last Updated
November 12, 2021
Record last verified: 2021-11