Condition category
Circulatory System
Date applied
29/11/2006
Date assigned
13/12/2006
Last edited
24/03/2011
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 Faisel Khan

ORCID ID

Contact details

Department of Vascular Medicine
Level 7
Ninewells Hospital
Dundee
DD1 9SY
United Kingdom
+44 (0)1382 635574
f.khan@dundee.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Res 02/ A60 2464/02/05

Study information

Scientific title

Acronym

Study hypothesis

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

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.

Study design

Randomised, double blinded , placebo controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Allopurinol

Primary outcome measures

Correlation between arterial stiffness and urate levels.

Secondary outcome measures

Effect of allopurinol on arterial stiffness.

Overall trial start date

01/02/2002

Overall trial end date

01/04/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Stroke survivors who have a high serum urate

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

120

Participant exclusion criteria

1. Documented reaction to allopurinol
2. Persons who were incapable of giving informed consent

Recruitment start date

01/02/2002

Recruitment end date

01/04/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Vascular Medicine
Dundee
DD1 9SY
United Kingdom

Sponsor information

Organisation

University of Dundee (UK)

Sponsor details

Nethergate
Dundee
DD1 4HN
United Kingdom
+44 (0)1382 660111 ext 33450
j.george@dundee.ac.uk

Sponsor type

University/education

Website

http://www.dundee.ac.uk

Funders

Funder type

Charity

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Heart Research UK (Grant Ref 2464/02/05)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/19035875

Publication citations

  1. Results

    Khan F, George J, Wong K, McSwiggan S, Struthers AD, Belch JJ, Allopurinol treatment reduces arterial wave reflection in stroke survivors., Cardiovasc Ther, 2008, 26, 4, 247-252, doi: 10.1111/j.1755-5922.2008.00057.x.

Additional files

Editorial Notes