Xanthine Oxidase Inhibition for Improvement of Long-term Outcomes Following Ischaemic Stroke and Transient Ischaemic Attack "XILO-FIST"

Recruiting

Phase 4 Results N/A

Trial Description

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.

Conditions

Interventions

  • Placebo Drug
    ARM 1: Kind: Experimental
    Label: Placebo
  • Allopurinol Drug
    Other Names: Zyloprim; Allohexal; Allosig; Milurit; Alloril; Progout; Zyloric; Puricos; Zyrik 300; Aluron
    ARM 1: Kind: Experimental
    Label: Allopurinol

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary White matter hyper-intensities (WMH) progression rate over 2 years, defined using the Rotterdam Progression Score 2 years No
Secondary change in mean day-time systolic BP at 1 month 1 month No
Secondary change in mean day-time diastolic BP at 1 month 1 month No
Secondary Schmidt's Progression Score 2 years No
Secondary Fazekas score 2 years No
Secondary Scheltens scale score 2 years No
Secondary New brain infarction on MRI 2 years No
Secondary Rotterdam Progression Score with those who die / become too frail to undergo MRI being assigned the highest score 2 years No
Secondary Montreal Cognitive Assessment (MoCA) score 2 years No
Secondary Incident dementia 2 years No
Secondary change in mean day-time systolic BP at 2 years 2 years No
Secondary change in mean day-time diastolic BP at 2 years 2 years No
Secondary blood pressure variability 2 years No
Secondary Quality of life (EQ-5D, Stroke Specific Quality of Life Scale (SS-QOL)) 2 years No
Secondary Recurrent stroke 2 years No
Secondary Recurrent myocardial infarction (MI), stroke or cardiac death 2 years No
Secondary Mortality 2 years No
Secondary Incident atrial fibrillation 2 years No
Secondary Clinic blood pressure 2 years No
Secondary Recurrent myocardial infarction (MI), stroke or cardiac death 2 years No

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