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    Summary
    EudraCT Number:2013-004235-77
    Sponsor's Protocol Code Number:XILO-FIST
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-03-12
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2013-004235-77
    A.3Full title of the trial
    Xanthine oxidase inhibition for improvement of long-term outcomes following ischaemic stroke and transient ischaemic attack (XILO-FIST).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Allopurinol, brain lesions, heart size and blood pressure after ischaemic stroke
    A.3.2Name or abbreviated title of the trial where available
    XILO-FIST
    A.4.1Sponsor's protocol code numberXILO-FIST
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02122718
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNHS Greater Glasgow & Clyde
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportStroke Association / British Heart Foundation
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNHS Greater Glasgow & Clyde
    B.5.2Functional name of contact pointTravers
    B.5.3 Address:
    B.5.3.1Street AddressResearch & Development
    B.5.3.2Town/ city2nd Floor West Glasgow Ambulatory Care Hospital
    B.5.3.3Post codeG3 8SW
    B.5.4Telephone number01412321813
    B.5.6E-mailmaureen.travers@ggc.scot.nhs.uk
    B.Sponsor: 2
    B.1.1Name of SponsorUniversity of Glasgow
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Allopurinol
    D.2.1.1.2Name of the Marketing Authorisation holderCrescent Pharma Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAllopurinol
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAllopurinol
    D.3.9.1CAS number 315-30-0
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Ischaemic stroke or transient ischaemic attack (TIA) (ICD Classification Code I63.0-9 and G45.0-1)
    E.1.1.1Medical condition in easily understood language
    Stroke due to blood clots or mini strokes.
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10061256
    E.1.2Term Ischaemic stroke
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10044390
    E.1.2Term Transient ischaemic attack
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. To establish whether a two year course of allopurinol 300 mg twice daily reduces WMH progression after ischaemic stroke.
    E.2.2Secondary objectives of the trial
    1. To establish whether allopurinol reduces BP after ischaemic stroke.
    2. To evaluate whether allopurinol reduces cognitive decline after ischaemic stroke.
    3. To evaluate whether allopurinol reduces vascular event rate after ischaemic stroke.

    Carotid plaque sub-analysis:
    1. To establish whether allopurinol improves carotid plaque measures after ischaemic stroke.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    XILO-FIST Cardiac Sub-study, Version 1. The objective of this sub-study is to establish whether allopurinol use reduces cardiac enlargement (left ventricular hypertrophy) in stroke survivors.

    The cardiac sub study has been termination due to lack of recruitment with the agreement of the TSC.

    A second sub study has been added.

    XILO-FIST 7T MRI sub study: the objective of this study is to generate initial 7T MRI data in people with cerebral small vessel disease and better understand the pathophysiology of features of SVD. We will 1) assess the morphology of vessels and arteries in areas of small vessel disease markers compared to normal appearing brain tissue; 2)perform a comparative analysis of MRI data at 3T and 7T MRI findings, cognition and other clinical variables.
    E.3Principal inclusion criteria
    1. Ischaemic Stroke.
    2. Age greater than 50 years.
    3. Ischaemic lesion on brain imaging in relevant anatomical territory in patients with transient ischaemic attack.
    4. Consent within one month of stroke.

    Ischaemic stroke will be diagnosed by a stroke specialist and defined as a focal neurological event lasting more than 24 hours or symptoms lasting less than 24 hours with positive diffusion weighted imaging or a corresponding lesion on CT. This inclusion criterion will be verified by local investigators following image review and this will be recorded in the patient record and on the eCRF.
    E.4Principal exclusion criteria
    1. Modified Rankin scale score of 5 (at end of the possible enrolment window of one month after stroke).
    2. Diagnosis of dementia (defined as a documented diagnosis or a screening IQCODE (Informant Questionnaire for Cognitive Decline in the Elderly) score of 3.6 or more).
    3. Cognitive impairment deemed sufficient to compromise capacity to consent or to comply with the protocol (in the opinion of the local investigator).
    4. 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).
    5. 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).
    6. 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).
    7. Concurrent azathioprine, 6-mercaptopurine therapy, other cytotoxic therapies, cyclosporin, theophylline and didanosine.
    8. Significant hepatic impairment (defined as serum bilirubin, AST or ALT greater than three times upper limit of normal (ULN)).
    9. Estimated Glomerular Filtration Rate < 30 mls/min
    10. Contraindication to MRI scanning.
    11. Women of childbearing potential.
    12. Prisoners.
    13. Active participation in another CTIMP or device trial or participation within the past month.
    14. eGFR < 60 and of Korean, Han Chinese or Thai descent

    Women of non-childbearing potential are defined as those who have no uterus, ligation of the fallopian tubes, or permanent cessation of ovarian function due to ovarian failure or surgical removal of the ovaries. A woman is also presumed to be infertile due to natural causes if she has been amenorrheic for greater than 12 months and has an FSH greater than 40 IU/L
    E.5 End points
    E.5.1Primary end point(s)
    WMH progression rate over 2 years, defined using the Rotterdam Progression Score.

    As of March 2020 we will extend the maximum duration of treatment from 104 weeks to 130 weeks, this has been done in response to the temporary shutdown of face to face contact at many sites due to the COVID19 restrictions.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Brain MRI will be performed at baseline and 2 years using either 1.5T or 3T MRI. The Rotterdam progression score will be calculated between baseline and subsequent scans. MRI analysis will be performed centrally at the core laboratory (University of Glasgow). This will be performed as soon as possible following the 2 year MRI scan being performed.
    E.5.2Secondary end point(s)
    1) change in mean day-time systolic BP at 1 month.
    2) change in mean day-time diastolic BP at 1 month
    3) Schmidt’s Progression Score
    4) WMH volume at 2 years
    5) New brain infarction on MRI
    6) Rotterdam Progression Score with those who die/become too ill to undergo
    7) MRI being assigned the highest score
    8) MoCA score
    9) Change in mean day-time systolic BP at 2 years
    10) Change in mean day-time diastolic BP at 2 years

    The following outcomes are exploratory
    - Fazekas score
    - Scheltens scale score
    - Blood pressure variability
    - One month mean day-time systolic blood pressure
    - One month mean day-time diastolic blood pressure
    - Clinic blood pressure
    - Incident atrial fibrillation
    - Recurrent stroke
    - Recurrent MI, stroke or cardiac death
    - Hospitalisation for, or incident of heart failure
    - Incident dementia
    - Mortality
    - Animal naming test
    - Controlled work association test
    - Hopkins verbal learning test
    - Trail making test
    - Quality of life (EQ-5D, SS-QOL)
    E.5.2.1Timepoint(s) of evaluation of this end point
    All secondary endpoints will be evaluated at 2 years with the exception of clinic blood pressure (which will be assessed at 1 month, 2 years and as a mean on treatment level) and MoCA score which will be assessed at week 52 months.

    As of March 2020 we will extend the maximum duration of treatment from 104 weeks to 130 weeks, this has been done in response to the temporary shutdown of face to face contact at many sites due to the COVID19 restrictions.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned12
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    For the purposes of regulatory requirements the end of the trial is defined as one month after the date of the last investigational visit for the last patient undergoing protocol treatment.

    This is in order to ensure that we can quality assess and review the final MRI image before the end of the study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days14
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 364
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state464
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 464
    F.4.2.2In the whole clinical trial 464
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Study drug will cease at the end of the study. Participants will then enter normal follow−up, which is likely to be led by their General Practitioner.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation NRS Scottish Stroke Research Network
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-01-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-06-24
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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