Ischaemic stroke or transient ischaemic attack (TIA) (ICD Classification Code I63.0-9 and G45.0-1). MedDRA version: 9.1 Level: LLT Classification code 10061256 Term: Ischaemic stroke
Conditions
Interventions
Product Name: Allopurinol
Pharmaceutical Form: Capsule*
INN or Proposed INN: Allopurinol
CAS Number: 315-30-0
Current Sponsor code: Allo
Sponsors
University of Glasgow / NHS Greater Glasgow and Clyde
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Ischaemic Stroke (including transient ischaemic attack (TIA) where symptoms last less than 24 hours). 2. Brain imaging not suggestive of an alternative diagnosis. 3. Randomisation within one year of ictus. Ischaemic stroke will be defined as suggestive clinical features which can be classified according to the Oxfordshire Community Stroke Project classification and have a presumed vascular occlusive cause. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. >70% extra-cranial internal carotid artery stenosis. 2. Significant co-morbidity or frailty likely to cause death within 12 months or likely to make adherence to study protocol difficult for participant. 3. Contra-indication to or indication for administration of allopurinol (as detailed in SmPC). 4. Concurrent azathioprine or 6-mercaptopurine therapy, other cytotoxic therapies, cyclosporine and didanosine. 5. Significant hepatic impairment as defined by serum bilirubin, AST or ALT greater than three times upper limit of normal. 6. eGFR < 50 mls/min. 7. Cognitive impairment deemed sufficient to compromise capacity to consent or to comply with the protocol. 8. Women of childbearing potential (defined as pre-menopausal and not having undergone hysterectomy). 9. Prisoners.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish whether allopurinol 300 mg given to a post stroke population leads to; 1. A trend toward a reduction in rate of carotid intima-media thickness progression rate (this a measure of the thickness of the arterial wall which links with cardiovascular risk). 2. An adverse side effect profile. 3. Changes in levels of circulating markers of endothelial function and levels of endothelial repair cells? ;Secondary Objective: Is a large scale therapeutic trial of the effect of allopurinol on IMT post stroke required and feasible? (Our data will inform power and sample size calculations for the larger trial). ;Primary end point(s): Change in carotid intima-media thickness (IMT) over a one year period (IMT progression rate). | — |
Countries
United Kingdom
Outcome results
None listed