Overview

XILO-FIST, the Effect of Allopurinol on the Brain Heart and Blood Pressure After Stroke

Status:
Unknown status
Trial end date:
2021-02-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
NHS Greater Glasgow and Clyde
Collaborator:
University of Glasgow
Treatments:
Allopurinol
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.