Condition category
Circulatory System
Date applied
19/09/2008
Date assigned
16/01/2009
Last edited
27/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Matthew Walters

ORCID ID

Contact details

Department of Medicine and Cardiovascular Sciences
Western Infirmary
Dumbarton Road
Glasgow
G11 6NT
United Kingdom
+44 (0)141 2112821
m.walters@clinmed.gla.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

TSA IMT 01

Study information

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

Study hypothesis

That allopurinol 300 mg per day will reduce rate of carotid intima-media thickness progression.

Ethics approval

West Medical Ethics Committee, approved on 19/08/2008.

Study design

Randomised double-blind placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Phase IV

Drug names

Allopurinol

Primary outcome measures

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 trial start date

01/11/2008

Overall trial end date

01/11/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80

Participant 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

Recruitment start date

01/11/2008

Recruitment end date

01/11/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Medicine and Cardiovascular Sciences
Glasgow
G11 6NT
United Kingdom

Sponsor information

Organisation

NHS Greater Glasgow and Clyde (UK)

Sponsor details

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
+44 (0)141 211 8544
erica.packard@ggc.scot.nhs.uk

Sponsor type

Government

Website

http://www.nhsgg.org.uk

Funders

Funder type

Charity

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24790069

Publication citations

  1. Results

    Higgins P, Walters MR, Murray HM, McArthur K, McConnachie A, Lees KR, Dawson J, Allopurinol reduces brachial and central blood pressure, and carotid intima-media thickness progression after ischaemic stroke and transient ischaemic attack: a randomised controlled trial., Heart, 2014, 100, 14, 1085-1092, doi: 10.1136/heartjnl-2014-305683.

Additional files

Editorial Notes