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Trial record 1 of 1 for:    XILO-FIST
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Xanthine Oxidase Inhibition for Improvement of Long-term Outcomes Following Ischaemic Stroke and Transient Ischaemic Attack (XILO-FIST)

This study is currently recruiting participants.
Verified September 2016 by NHS Greater Glasgow and Clyde
Sponsor:
ClinicalTrials.gov Identifier:
NCT02122718
First Posted: April 24, 2014
Last Update Posted: September 15, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
University of Glasgow
Information provided by (Responsible Party):
NHS Greater Glasgow and Clyde
  Purpose

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.


Condition Intervention Phase
Ischaemic Stroke Drug: Allopurinol Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Xanthine Oxidase Inhibition for Improvement of Long-term Outcomes Following Ischaemic Stroke and Transient Ischaemic Attack

Resource links provided by NLM:


Further study details as provided by NHS Greater Glasgow and Clyde:

Primary Outcome Measures:
  • White matter hyper-intensities (WMH) progression rate over 2 years, defined using the Rotterdam Progression Score [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • Cardiac sub-study: Change in measured Left ventricular mass (LVM) at 2 years [ Time Frame: 2 years ]
  • Cardiac sub-study: change in ejection fraction [ Time Frame: 2 years ]
  • Cardiac Sub-study: change in end diastolic volume [ Time Frame: 2 years ]
  • Cardiac sub-study: change in end systolic volume [ Time Frame: 2 years ]
  • Cardiac Sub-study: change in stroke volume [ Time Frame: 2 years ]
  • Cardiac sub-study: change in left atrial diameter [ Time Frame: 2 years ]

Estimated Enrollment: 464
Study Start Date: May 2014
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Allopurinol Drug: Allopurinol
Placebo Comparator: Placebo Drug: Placebo

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02122718


Contacts
Contact: Jesse Dawson, MD, BSc (hon), MBChB (hons), 0141 451 5868 jesse.dawson@glasgow.ac.uk
Contact: Pamela MacKenzie 0141 451 5871 Pamela.MacKenzie@glasgow.ac.uk

Locations
United Kingdom
NHS Grampian Recruiting
Aberdeen, United Kingdom, AB25 2ZD
Contact: Mary MacLeod         
NHS Lanarkshire Recruiting
Airdrie, United Kingdom, ML6 0JS
Contact: Mark Barber         
Dartford and Gravesham NHS Trust Recruiting
Dartford, Kent, United Kingdom, DA2 8DA
Contact: Imran Ashraf         
NHS Tayside Recruiting
Dundee, United Kingdom, DD1 9SY
Contact: Allan Struthers         
NHS Greater Glagsow and Clyde Recruiting
Glasgow, United Kingdom, G11 6NT
Contact: Jesse Dawson         
Leeds Teaching Hospitals NHS Trust Recruiting
Leeds, United Kingdom, LS1 3EX
Contact: Ahamad Hassan         
Guys and St Thomas NHS Foundation Trust Recruiting
London, United Kingdom, SE1 7EH
Contact: Ajay Bhalla         
Newcastle UPon Tyne Hospitals NHS Trust Recruiting
Newcastle, United Kingdom, NE2 4AB
Contact: Alezander Dyker         
Northumbria NHS Trust Recruiting
Northumbria, United Kingdom, NE63 9JJ
Contact: Christopher Price         
Nottingham University Recruiting
Nottingham, United Kingdom, NG5 1PB
Contact: Ganesh Subramanian         
City Hospital Sunderland NHS Foundation Trust Recruiting
Sunderland, United Kingdom, SR4 7TP
Contact: Naweed Sattar         
Sponsors and Collaborators
NHS Greater Glasgow and Clyde
University of Glasgow
Investigators
Principal Investigator: Jesse Dawson University of Glasgow
  More Information

Responsible Party: NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier: NCT02122718     History of Changes
Other Study ID Numbers: GN12MT494
TSA BHF 2013/01 ( Other Grant/Funding Number: The Stroke Association )
First Submitted: April 23, 2014
First Posted: April 24, 2014
Last Update Posted: September 15, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Stroke
Ischemia
Cerebral Infarction
Ischemic Attack, Transient
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Allopurinol
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Antioxidants
Protective Agents
Physiological Effects of Drugs