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

Recruiting

Phase 4 Results N/A

Update History

16 Sep '16
The eligibility criteria were updated.
New
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.
Old
Inclusion Criteria: - Ischaemic Stroke - Age greater than 50 years. - Ischaemic lesion on brain imaging in relevant anatomical territory in patients with transient ischaemic attack. - 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.
A location was updated in Dundee.
New
The overall status was updated to "Recruiting" at NHS Tayside.
A location was updated in Glasgow.
New
The overall status was updated to "Recruiting" at NHS Greater Glagsow and Clyde.