Allopurinol and cardiovascular outcomes in patients with ischaemic heart disease

Plain English Summary

Background and study aims
Allopurinol is a medication used to prevent gout. Allopurinol has several positive effects on heart and blood vessels, is inexpensive and is already widely used in patients. Ischaemic heart disease (heart attack) is the most common cause of death in people in the UK and treatment of patients with ischaemic heart disease costs the NHS billions of pounds each year. In this study, we want to improve the treatment of patients with ischaemic heart disease. We want to investigate whether adding allopurinol to these patients’ usual medications will reduce their risk of having a stroke, heart attack or of dying due to cardiovascular disease.

Who can participate?
Patients 60 years and over with ischaemic heart disease (IHD) can participate in the study

What does the study involve?
Patients will attend their local primary care centre (general practice) to take part in the study. Patients will be randomly allocated to receive 600mg daily allopurinol (300mg daily in those patients with mild to moderate renal impairment at screening) or no treatment in addition to their usual medications. They will then will be followed up for a period of around 4 years to count the number of heart attacks, strokes and cardiovascular deaths that occur. The numbers of these events that occur in different treatment groups will be compared to see if there is a benefit of adding allopurinol to their ongoing treatment. Most of the follow-up information will be collected electronically by accessing centrally held electronic records of hospital admissions and deaths, which will make the study easier for patients and more cost-efficient. We will also measure the quality of life and whether there is a cost benefit of using allopurinol in patients with ischaemic heart disease.

What are the possible benefits and risks of participating?
Although we are doing the study to find out whether allopurinol reduces the risk of heart attack, stroke and cardiovascular death in patients with ischaemic heart disease, there may be no direct benefit to a patient of taking part in this study. Some patients might experience side effects due to taking allopurinol, for example, rash, nausea or vomiting.

Where is the study run from?
Medicines Monitoring Unit (MEMO), University of Dundee/Ninewells Hospital (lead centre) and eight other hospitals in Northern England and Scotland (UK)

When is the study starting and how long is it expected to run for?
September 2013 to March 2022

Who is funding the study?
National Institute of Health Research (UK)

Who is the main contact?
Prof. Isla Mackenzie
i.s.mackenzie@dundee.ac.uk

Study website

Contact information

Prof Isla Mackenzie
Scientific

MEMO/HRC
University of Dundee
Level 7, Ninewells Hospital
Dundee
DD1 9SY
United Kingdom

ORCID ID	0000-0002-3680-7127
Phone	+44 1382 383119
Email	i.s.mackenzie@dundee.ac.uk

Study information

Eligibility

Locations

Countries of recruitment

• England
• Scotland
• United Kingdom

Study participating centres

Sponsor information

The University of Dundee (UK)
University/education

c/o Tricia Burns
Tayside medical Sciences Centre (TASC)
Level 4 Ninewells Hospital
Dundee
DD1 9SY
Scotland
United Kingdom

"ROR"	https://ror.org/03h2bxq36

Funders

Funder type

Government

Results and Publications

Study outputs

Editorial Notes

03/04/2024: Publication reference added.
11/10/2022: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
28/03/2022: The intention to publish date has been changed from 30/04/2022 to 31/08/2022.
09/02/2021: The following changes were made to the trial record:
1. The overall trial end date was changed from 31/03/2021 to 31/03/2022.
2. The intention to publish date was changed from 31/12/2021 to 30/04/2022.
3. Contact details updated.
4. IPD sharing statement added.
23/11/2020: The following changes have been made:
1. The recruitment start date has been changed from 01/09/2013 to 07/02/2014.
2. The overall trial end date has been changed from 31/05/2019 to 31/03/2021 and the plain English summary has been updated accordingly.
3. The trial website has been updated.
09/04/2018: The following changes have been made:
1. The recruitment end date has been changed from 31/05/2019 to 29/09/2017.
2. Trial centres in Airdrie, East Kilbride, Brighton, York, Exeter, Liverpool and Nottingham have been added.
12/09/2016: Publication reference added.
03/05/2016: Further trial participating centres in Nottingham, Aberdeen, Ayrshire & Arran, Dumfries and Galloway, Edinburgh, Glasgow, Inverness and Newcastle have been added. Ethics approval information added.
20/04/2016: On 04/04/2016, a protocol amendment was implemented to allow the inclusion of patients with mild to moderate renal impairment in the study. Exclusion criterion 2 has been amended from ‘Known renal impairment (eGFR<60 ml/min)’ to ‘Known severe renal impairment (eGFR <30 ml/min)’. Patients with eGFR 30-59 ml/min at their screening visit will receive a maximum dose of 300 mg daily allopurinol in the study (instead of 600 mg daily) - the interventions section has been updated to reflect this.