Ischaemic StrokePhase 4XILO-FISTNCT02122718
XILO-FIST, the Effect of Allopurinol on the Brain Heart and Blood Pressure After Stroke
A Phase 4 study testing Allopurinol in people with Ischaemic Stroke, run by NHS Greater Glasgow and Clyde at 21 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Ischaemic Stroke
- What is being tested?
- Allopurinol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 464 participants
- Where
- 21 sitesUnited Kingdom
- Study dates
- May 2014to Feb 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United Kingdom21 sites
NHS Grampian
Aberdeen, AB25 2ZD
NHS Lanarkshire
Airdrie, ML6 0JS
Northumbria NHS Trust
Ashington, Northumberland, NE63 9JJ
Royal United Hospital
Bath, Somerset, BA1 3NG
Broomfield Hospital
Chelmsford, Essex, CM1 7ET
Darent Valley Hospital
Dartford, Kent, DA2 8DA
NHS Tayside
Dundee, DD1 9SY
South West Acute Hospital
Enniskillen, BT74 6DN
NHS Greater Glagsow and Clyde
Glasgow, G11 6NT
Leeds Teaching Hospitals NHS Trust
Leeds, LS1 3EX
Barnet Hospital
London, EN5 3DJ
Guys and St Thomas NHS Foundation Trust
London, SE1 7EH
UCL Stroke Research Centre
London, WC1B 5EH
Altnagelvin Campus
Londonderry, County Derry, BT47 6SB
Luton and Dunstable University Hosptial
Luton, LU4 0DZ
Newcastle UPon Tyne Hospitals NHS Trust
Newcastle, NE2 4AB
Nottingham University
Nottingham, NG5 1PB
Royal Stoke University Hosptial
Stoke-on-Trent, Staffordshire, ST4 6QG
City Hospital Sunderland NHS Foundation Trust
Sunderland, SR4 7TP
Southend University Hospital
Westcliff-on-Sea, Essex, SS0 0RY
The Royal London Hospital
Whitechapel, London, E1 1BB
About this study
Official title: Xanthine Oxidase Inhibition for Improvement of Long-term Outcomes Following Ischaemic Stroke and Transient Ischaemic Attack
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.
Read the detailed description
New strategies are needed to improve long-term outcomes after ischaemic stroke or transient ischaemic attack (TIA). Approximately 13% of participants suffered recurrent stroke in recent secondary preventative trials , 40% of patients with TIA experience recurrent cardiovascular (CV) events during long-term follow up and there is an additional substantial burden from incident post-stroke dementia (~ 10% after first stroke and higher still after recurrent events) , cognitive decline (over 30%) and decline in physical function. Improving these outcomes is a recognised priority area for stroke research (as identified by stroke survivors through the recent James Lind Alliance priority setting workshops ).
Such adverse outcomes are particularly common in those with brain white matter hyper-intensities (WMH) on brain magnetic resonance imaging (MRI) . WMH are seen in as many as 90% of patients with ischaemic stroke , , are at least moderately severe in 50%6 and such 'severe' WMH are associated with substantially higher stroke recurrence rates (43% in one study)6, death and increased cognitive and physical decline. The burden of WMH increases during longitudinal follow up and this is associated with increased incident stroke, dementia and cognitive decline5. In the longitudinal population based Rotterdam scan study, 39% of elderly participants had WMH progression (over a mean period of 3.4 years) , as did 50% in the recent PROFeSS MRI sub-study (over 2 years)7 and 74% (over 3 years) in the Leukoariosis and Disability study (LADIS) .Similarly, silent brain infarction (SBI) is also associated with recurrent stroke and 14% developed incident infarcts on brain MRI in the Rotterdam scan study9. Thus, treatments that reduce WMH progression and incident silent brain infarction could have potentially profound effects on a variety of outcomes after stroke including cognition, functional outcome and recurrent stroke.
The pathological basis for WMH development and progression is poorly understood. Post mortem studies show presence of varied pathologies including demyelination, infarction, arteriosclerosis and breakdown of the blood-brain barrier. Key risk factors for development and progression of WMH are age, arterial hypertension and previous stroke9 and associations with other cardiovascular risk factors and left ventricular hypertrophy (LVH) have been demonstrated . Blood pressure (BP) lowering reduces WMH progression, as demonstrated by the PROGRESS MRI sub-study . In the PROFeSS MRI sub-study WMH progression was unaffected by the angiotensin receptor blocker telmisartan7 but unlike PROGRESS, there was no significant difference in BP between groups. In addition, WMH are less clearly related to hypertension in older patients with established cardiovascular disease meaning that novel strategies which reduce WMH progression and SBI would be particularly promising in this group.
The association between WMH and LVH is of particular interest; it appears independent of arterial BP , and may be mediated by aortic stiffness . There are additional potential mechanisms for this association (e.g., LVH is the strongest predictor of left atrial appendage thrombi, stronger than any left atrial parameter) . Regression of LVH is associated with reduced risk of stroke. In a recent meta-analysis of 14 studies in 12,809 patients, LVH regression was independently associated with a 25% reduction in future strokes, whereas the composite endpoint of CV events/mortality was only 15% lower . Similar findings were seen in the LIFE echo sub-study which utilised measures of left ventricular mass (LVM) . LVH regression is thus a promising therapeutic target in devising new ways to prevent strokes, especially if the same treatment were found to reduce WMH.
- Conditions
- Ischaemic Stroke
- Being tested
- Allopurinol, Placebo
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AllopurinolDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Allopurinol | Experimental | Not described Receives: Drug: Allopurinol |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
White matter hyper-intensities (WMH) progression rate over 2 years, defined using the Rotterdam Progression Score
Measured: 2 years
Secondary outcomes (18)
change in mean day-time systolic BP at 1 month
Measured: 1 month
change in mean day-time diastolic BP at 1 month
Measured: 1 month
Schmidt's Progression Score
Measured: 2 years
Fazekas score
Measured: 2 years
Scheltens scale score
Measured: 2 years
New brain infarction on MRI
Measured: 2 years
Rotterdam Progression Score with those who die / become too frail to undergo MRI being assigned the highest score
Measured: 2 years
Montreal Cognitive Assessment (MoCA) score
Measured: 2 years
Incident dementia
Measured: 2 years
change in mean day-time systolic BP at 2 years
Measured: 2 years
change in mean day-time diastolic BP at 2 years
Measured: 2 years
blood pressure variability
Measured: 2 years
Quality of life (EQ-5D, Stroke Specific Quality of Life Scale (SS-QOL))
Measured: 2 years
Recurrent stroke
Measured: 2 years
Recurrent myocardial infarction (MI), stroke or cardiac death
Measured: 2 years
Mortality
Measured: 2 years
Incident atrial fibrillation
Measured: 2 years
Clinic blood pressure
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionFeb 2021
- Study completionFeb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ischaemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 464 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow
- Responsible party
- Sponsor
- Investigators
- Jesse Dawson, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02122718
- Sponsor's protocol ID
- GN12MT494
- Other IDs
- TSA BHF 2013/01
- Acronym
- XILO-FIST
- Status last verified
- Nov 2021
- First submitted
- 23 Apr 2014
- Last updated
- 12 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 36864979Dawson 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.
PubMed 30246149
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xanthine Oxidase Inhibition for Improvement of Long-term Outcomes Following Ischaemic Stroke and Transient Ischaemic Attack
- ClinicalTrials.gov ID
- NCT02122718
- Acronym / sponsor ID
- XILO-FIST / GN12MT494
- Conditions
- Ischaemic Stroke
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 464 participants (actual)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- University of Glasgow
- Study start
- May 2014
- Primary completion
- Feb 2021 (actual)
- Study completion
- Feb 2021 (actual)
- First posted
- 24 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
New strategies are needed to improve long-term outcomes after ischaemic stroke or transient ischaemic attack (TIA). Approximately 13% of participants suffered recurrent stroke in recent secondary preventative trials , 40% of patients with TIA experience recurrent cardiovascular (CV) events during long-term follow up and there is an additional substantial burden from incident post-stroke dementia (~ 10% after first stroke and higher still after recurrent events) , cognitive decline (over 30%) and decline in physical function. Improving these outcomes is a recognised priority area for stroke research (as identified by stroke survivors through the recent James Lind Alliance priority setting workshops ).
Such adverse outcomes are particularly common in those with brain white matter hyper-intensities (WMH) on brain magnetic resonance imaging (MRI) . WMH are seen in as many as 90% of patients with ischaemic stroke , , are at least moderately severe in 50%6 and such 'severe' WMH are associated with substantially higher stroke recurrence rates (43% in one study)6, death and increased cognitive and physical decline. The burden of WMH increases during longitudinal follow up and this is associated with increased incident stroke, dementia and cognitive decline5. In the longitudinal population based Rotterdam scan study, 39% of elderly participants had WMH progression (over a mean period of 3.4 years) , as did 50% in the recent PROFeSS MRI sub-study (over 2 years)7 and 74% (over 3 years) in the Leukoariosis and Disability study (LADIS) .Similarly, silent brain infarction (SBI) is also associated with recurrent stroke and 14% developed incident infarcts on brain MRI in the Rotterdam scan study9. Thus, treatments that reduce WMH progression and incident silent brain infarction could have potentially profound effects on a variety of outcomes after stroke including cognition, functional outcome and recurrent stroke.
The pathological basis for WMH development and progression is poorly understood. Post mortem studies show presence of varied pathologies including demyelination, infarction, arteriosclerosis and breakdown of the blood-brain barrier. Key risk factors for development and progression of WMH are age, arterial hypertension and previous stroke9 and associations with other cardiovascular risk factors and left ventricular hypertrophy (LVH) have been demonstrated . Blood pressure (BP) lowering reduces WMH progression, as demonstrated by the PROGRESS MRI sub-study . In the PROFeSS MRI sub-study WMH progression was unaffected by the angiotensin receptor blocker telmisartan7 but unlike PROGRESS, there was no significant difference in BP between groups. In addition, WMH are less clearly related to hypertension in older patients with established cardiovascular disease meaning that novel strategies which reduce WMH progression and SBI would be particularly promising in this group.
The association between WMH and LVH is of particular interest; it appears independent of arterial BP , and may be mediated by aortic stiffness . There are additional potential mechanisms for this association (e.g., LVH is the strongest predictor of left atrial appendage thrombi, stronger than any left atrial parameter) . Regression of LVH is associated with reduced risk of stroke. In a recent meta-analysis of 14 studies in 12,809 patients, LVH regression was independently associated with a 25% reduction in future strokes, whereas the composite endpoint of CV events/mortality was only 15% lower . Similar findings were seen in the LIFE echo sub-study which utilised measures of left ventricular mass (LVM) . LVH regression is thus a promising therapeutic target in devising new ways to prevent strokes, especially if the same treatment were found to reduce WMH.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Allopurinol | Experimental | Drug: Allopurinol |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (14 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allopurinol | Drug | Allopurinol |
| Placebo | Drug | Placebo |
Primary outcome
White matter hyper-intensities (WMH) progression rate over 2 years, defined using the Rotterdam Progression Score
Time frame: 2 years
18 secondary outcomes
change in mean day-time systolic BP at 1 month
Time frame: 1 month
change in mean day-time diastolic BP at 1 month
Time frame: 1 month
Schmidt's Progression Score
Time frame: 2 years
Fazekas score
Time frame: 2 years
Scheltens scale score
Time frame: 2 years
New brain infarction on MRI
Time frame: 2 years
Rotterdam Progression Score with those who die / become too frail to undergo MRI being assigned the highest score
Time frame: 2 years
Montreal Cognitive Assessment (MoCA) score
Time frame: 2 years
Incident dementia
Time frame: 2 years
change in mean day-time systolic BP at 2 years
Time frame: 2 years
change in mean day-time diastolic BP at 2 years
Time frame: 2 years
blood pressure variability
Time frame: 2 years
Quality of life (EQ-5D, Stroke Specific Quality of Life Scale (SS-QOL))
Time frame: 2 years
Recurrent stroke
Time frame: 2 years
Recurrent myocardial infarction (MI), stroke or cardiac death
Time frame: 2 years
Mortality
Time frame: 2 years
Incident atrial fibrillation
Time frame: 2 years
Clinic blood pressure
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2021.
- Derived from this study: PubMed 36864979Dawson 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.
- Derived from this study: PubMed 30246149Dawson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jesse Dawson principal investigator
University of Glasgow
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Allopurinol in people with Ischaemic Stroke, run by NHS Greater Glasgow and Clyde at 21 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
White matter hyper-intensities (WMH) progression rate over 2 years, defined using the Rotterdam Progression Score (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02122718, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2021.