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| [ ...Back to search results ] | [ Print-friendly version ] |
| The effect of allopurinol on carotid ultrasound intima-media thickness and markers of endothelial function in patients with recent stroke - a pilot study |
| ISRCTN | ISRCTN11970568 |
| ClinicalTrials.gov identifier | |
| Public title | The effect of allopurinol on carotid ultrasound intima-media thickness and markers of endothelial function in patients with recent stroke - a pilot study |
| Scientific title | The effect of allopurinol on carotid ultrasound intima-media thickness and markers of endothelial function in patients with recent stroke: a double-blind randomised placebo-controlled pilot trial |
| Acronym | N/A |
| Serial number at source | TSA IMT 01 |
| Study hypothesis | That allopurinol 300 mg per day will reduce rate of carotid intima-media thickness progression. |
| Lay summary | |
| Ethics approval | West Medical Ethics Committee, approved on 19/08/2008. |
| Study design | Randomised double-blind placebo-controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Cerebral infarction and transient ischaemic attack |
| Participants - inclusion criteria |
1. Both males and females, aged over 18
2. Ischaemic Stroke (including transient ischaemic attack [TIA] where symptoms last less than 24 hours) 3. Brain imaging not suggestive of an alternative diagnosis 4. Randomisation within one year of ictus |
| Participants - 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 4. Concurrent azathioprine or 6-mercaptopurine therapy 5. Significant hepatic impairment (defined as serum bilirubin, aspartate aminotransferase [AST] or alanine aminotransferase [ALT] greater than three times upper limit of normal [ULN]) 6. Estimated glomerular filtration rate <50 mls/min 7. Cognitive impairment deemed sufficient to compromise capacity to consent or to comply with the protocol 8. Women of childbearing potential 9. Prisoners |
| Anticipated start date | 01/11/2008 |
| Anticipated end date | 01/11/2011 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 80 |
| Interventions |
One year course of allopurinol (oral) 300 mg per day or placebo.
Details of Joint Sponsor: University of Glasgow University Avenue Glasgow G12 8QQ United Kingdom |
| Primary outcome measure(s) | Change in carotid intima-media thickness over a one year period (intima-media thickness [IMT] progression rate). |
| Secondary outcome measure(s) |
The following will be assessed at baseline, 6 and 12 months:
1. Levels of endothelial progenitor cells (EPCs) and circulating markers of endothelial function 2. Number of adverse events |
| Sources of funding | The Stroke Association (UK) (ref: TSA 2007/10) |
| Trial website | |
| Publications | |
| Contact name | Dr Matthew Walters |
| Address |
Department of Medicine and Cardiovascular Sciences
Western Infirmary Dumbarton Road |
| City/town | Glasgow |
| Zip/Postcode | G11 6NT |
| Country | United Kingdom |
| Tel | +44 (0)141 2112821 |
| m.walters@clinmed.gla.ac.uk | |
| Sponsor | NHS Greater Glasgow and Clyde (UK) |
| Address |
c/o Dr Erica Packard
Academic Research Co-ordinator Research and Development Central Office First Floor The Tennent Institute 38 Church Street Western Infirmary |
| City/town | Glasgow |
| Zip/Postcode | G11 6NT |
| Country | United Kingdom |
| Tel | +44 (0)141 211 8544 |
| erica.packard@ggc.scot.nhs.uk | |
| Sponsor website: | http://www.nhsgg.org.uk |
| Date applied | 19/09/2008 |
| Last edited | 16/01/2009 |
| Date ISRCTN assigned | 16/01/2009 |
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