Allopurinol and cardiovascular outcomes in patients with ischaemic heart disease (IHD) | Recruiting
Allopurinol and cardiovascular outcomes in patients with ischaemic heart disease (IHD)
ALL-HEART
Trial Source

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Health Conditions
  • Ischaemic heart disease (IHD)
Dr Isla Mackenzie
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Primary Contact Details
Recruiting
Recruitment Status
ISRCTN32017426
Primary Trial ID Number
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 patientsÂ’ 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 allopurinol (600 mg daily) 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? The study is run from the Medicines Monitoring Unit (MEMO), University of Dundee / Ninewells Hospital, Dundee, UK. When is study starting and how long is it expected to run for? The study will start in September 2013 and is expected to run until May 2019. Who is funding the study? National Institute of Health Research (NIHR), UK. Who is the main contact? Dr Isla Mackenzie isla@memo.dundee.ac.uk
Research Details
  • The hypothesis of the study is that adding allopurinol 600mg daily to usual therapy will improve cardiovascular outcomes in patients aged over 60 with ischaemic heart disease.
Phase
Not Specified
Study Design
Multi-centre controlled prospective randomised open-label blinded endpoint (PROBE) trial
Study Type
Interventional
Intervention

Patients are randomised to two groups: 1. Receive standard care plus allopurinol (600 mg daily) 2. Standard care alone They will be followed up for a period of around 4 years. Most of the follow up data will be collected electronically by accessing centrally held electronic records of hospital admissions and deaths

Intervention Type
Drug
Primary Outcome Measures
  • The primary outcome will be the composite (APTC) CV endpoint of non-fatal myocardial infarction (MI), non-fatal stroke and CV death.
Secondary Outcome Measures
  • 1. Non-fatal MI
  • 2. Non-fatal stroke
  • 3. CV death
  • 4. All-cause mortality
  • 5. All CV hospitalisations
  • 6. Hospitalisation for acute coronary syndrome (ACS)
  • 7. Coronary revascularisation
  • 8. Hospitalisation for ACS or revascularisation
  • 9. Hospitalisation for heart failure
  • 10. Quality of life and cost effectiveness of allopurinol.
Publication(s)
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Result Reports
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Gender
Both
Age Range
Senior
Who Can Participate
Patient
Number of Participants
5215
Participant Inclusion Criteria
  • 1. Male or female patients aged 60 years and over.
  • 2. Ischaemic heart disease (IHD) defined as a diagnosis of angina or myocardial infarction (MI) at any time or other evidence ofischaemic heart disease (investigator opinion).
Participant Exclusion Criteria
  • 1. History of gout
  • 2. Known renal impairment (eGFR <60 ml/min).
  • 3. Moderate to severe heart failure (NYHA III-IV).
  • 4. Significant hepatic disease (eg ALT >3 x upper limit of normal, cirrhosis, ascites) (investigator opinion)
  • 5. Patients currently taking part in another interventional clinical trial of an investigational medicinal product or medical device (or taken part in one within the last 3 months).
  • 6. Previous allergy to allopurinol
  • 7. Previous serious adverse cutaneous (skin) reaction to any drug (eg Stevens Johnson syndrome, toxic epidermal necrolysis, hospitalisation due to skin reaction to drug) (investigator opinion)
  • 8. Patients already taking urate lowering therapy (including allopurinol, febuxostat, sulfinpyrazone, benzbromarone, probenecid, rasburicase).
  • 9. Patients taking azathioprine, mercaptopurine, ciclosporin or theophylline.
  • 10. Malignancy (except non-metastatic, non-melanoma skin cancers, cervical in-situ carcinoma, breast ductal carcinoma in situ, or stage 1 prostate carcinoma) within the last 5 years (investigator opinion).
Trial Location(s)
Research Site
Dundee
DD1 9SY
Trial Contact(s)
Primary Trial Contact
Dr Isla Mackenzie
Other Trial Contacts
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Countries Recruiting
United Kingdom
Scientific Title
Allopurinol and cardiovascular outcomes in patients with ischaemic heart disease (ALL-HEART): a randomised controlled trial
EudraCT Number
Sorry, this information is not available
Funder(s)
  • National Institute of Health Research (NIHR) Heath Technology Assessment Programme (HTA) Ref: 11/36/41
Other Study ID Numbers
ALL-HEART
Sponsor(s)
The University of Dundee (UK)
Key Dates

Recruitment Start Date

01 Sep 2013

Recruitment End Date

31 May 2019

Trial Start Date

01 Sep 2013

Trial End Date

31 May 2019

Date Assigned

16 Aug 2013

Last Updated

16 Aug 2013