Does allopurinol/urate lowering by xanthine oxidase inhibition have an impact on arterial stiffness in stroke survivors?

ISRCTN	ISRCTN98638368
DOI	https://doi.org/10.1186/ISRCTN98638368
Secondary identifying numbers	Res 02/ A60 2464/02/05

Submission date: 29/11/2006
Registration date: 13/12/2006
Last edited: 24/03/2011

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 Faisel Khan
Scientific

Department of Vascular Medicine
Level 7
Ninewells Hospital
Dundee
DD1 9SY
United Kingdom

Phone	+44 (0)1382 635574
Email	f.khan@dundee.ac.uk

Study information

Study design	Randomised, double blinded , placebo controlled study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study objectives	After the first year of an ischaemic cerebrovascular event (stroke), cardiovascular disease becomes the most common cause of death. A growing body of evidence suggests that serum uric acid is an independent marker of cardiovascular risk. We have shown previously that high urate is associated with cardiac death in 354 stroke survivors who were followed up for a median of 2.8 years, independently of conventional risk factors for atherosclerosis, creatinine and diuretic use. A larger study by Weir et. al., confirmed these findings and showed that higher serum urate levels, measured on admission to hospital, predicted poor outcome and higher future vascular events after acute stroke. We sought therefore to determine how uric acid levels correlate with arterial stiffness in those who have cardiovascular disease i.e. stroke survivors. Additionally, several studies have shown that allopurinol improves endothelial function, but its effect on arterial stiffness is not known and finding this out was our second aim.
Ethics approval(s)	Ethical approval for the study was obtained from the local ethics committee (Tayside Medical Ethics Committee, Scotland) and all subjects gave written, informed consent. All study related procedures were conducted according to institutional guidelines and the Declaration of Helsinki.
Health condition(s) or problem(s) studied	Stroke
Intervention	Patients were randomly allocated to receive either allopurinol 300 mg once daily or matched placebo. Baseline measurements were taken as part of the initial study and follow-up measurements were made after eight weeks of treatment. Patients attended for one additional visit at two weeks, non-fasted, for measurements of urea and electrolytes, liver function testing, and for monitoring of any adverse reactions.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Allopurinol
Primary outcome measure	Correlation between arterial stiffness and urate levels.
Secondary outcome measures	Effect of allopurinol on arterial stiffness.
Overall study start date	01/02/2002
Completion date	01/04/2003

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	120
Key inclusion criteria	Stroke survivors who have a high serum urate
Key exclusion criteria	1. Documented reaction to allopurinol 2. Persons who were incapable of giving informed consent
Date of first enrolment	01/02/2002
Date of final enrolment	01/04/2003

Locations

Countries of recruitment

Scotland
United Kingdom

Study participating centre

Department of Vascular Medicine

Dundee
DD1 9SY
United Kingdom

Sponsor information

University of Dundee (UK)
University/education

Nethergate
Dundee
DD1 4HN
Scotland
United Kingdom

Phone	+44 (0)1382 660111 ext 33450
Email	j.george@dundee.ac.uk
Website	http://www.dundee.ac.uk
"ROR"	https://ror.org/03h2bxq36

Funders

Funder type

Charity

Chest Heart and Stroke Scotland (Grant Ref: Res 02/ A60)

No information available

Heart Research UK (Grant Ref 2464/02/05)
Private sector organisation / Other non-profit organizations

Location: United Kingdom

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	01/11/2008		Yes	No