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
DOI	https://doi.org/10.1186/ISRCTN11970568
Secondary identifying numbers	TSA IMT 01

Submission date: 19/09/2008
Registration date: 16/01/2009
Last edited: 27/06/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Matthew Walters
Scientific

Department of Medicine and Cardiovascular Sciences
Western Infirmary
Dumbarton Road
Glasgow
G11 6NT
United Kingdom

Phone	+44 (0)141 2112821
Email	m.walters@clinmed.gla.ac.uk

Study information

Study design	Randomised double-blind placebo-controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Prevention
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study objectives	That allopurinol 300 mg per day will reduce rate of carotid intima-media thickness progression.
Ethics approval(s)	West Medical Ethics Committee, approved on 19/08/2008.
Health condition(s) or problem(s) studied	Cerebral infarction and transient ischaemic attack
Intervention	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
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Phase IV
Drug / device / biological / vaccine name(s)	Allopurinol
Primary outcome measure	Change in carotid intima-media thickness over a one year period (intima-media thickness [IMT] progression rate).
Secondary outcome measures	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
Overall study start date	01/11/2008
Completion date	01/11/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	80
Key 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
Key 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
Date of first enrolment	01/11/2008
Date of final enrolment	01/11/2011

Locations

Countries of recruitment

Scotland
United Kingdom

Study participating centre

Department of Medicine and Cardiovascular Sciences

Glasgow
G11 6NT
United Kingdom

Sponsor information

NHS Greater Glasgow and Clyde (UK)
Government

c/o Dr Erica Packard
Academic Research Co-ordinator
Research and Development Central Office
First Floor
The Tennent Institute
38 Church Street
Western Infirmary
Glasgow
G11 6NT
United Kingdom

Phone	+44 (0)141 211 8544
Email	erica.packard@ggc.scot.nhs.uk
Website	http://www.nhsgg.org.uk
"ROR"	https://ror.org/05kdz4d87

Funders

Funder type

Charity

The Stroke Association (UK) (ref: TSA 2007/10)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2014		Yes	No