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

Health Conditions
  • Ischaemic heart disease (IHD)
Recruiting
Recruitment Status
ISRCTN32017426
Primary Trial ID Number
Summary
Allopurinol is a medication used to prevent gout. Allopurinol has several positive effects on the cardiovascular system, is inexpensive and is already widely used in patients. Ischaemic heart disease (angina or heart attack) is the commonest 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 600mg daily to these patients' usual medications will reduce their risk of having a stroke, heart attack or dying due to cardiovascular disease. Patients will usually attend their local primary care centre (general practice) to take part in the study. Patients will be randomly allocated to receive allopurinol or no treatment in addition to their usual medications 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 other treatment. Most of the follow up data 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-effective. We will also measure quality of life and whether there is an economic benefit of using allopurinol in patients with ischaemic heart disease.
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.
Research Question
  • 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.
Design Type
Sorry, this information is not available
Ethics Approval
Pending
Publications
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Countries of Recruitment
United Kingdom
Participant Sex
Both
Participant Age Range
Senior
Participant Type
Patient
Trial Sample Size
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).
Interventions
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
Design Details
Sorry, this information is not available
Study Design
Multi-centre controlled prospective randomised open-label blinded endpoint (PROBE) trial
Results Reporting
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Acronym
ALL-HEART
Scientific Title
Allopurinol and cardiovascular outcomes in patients with ischaemic heart disease (ALL-HEART): a randomised controlled trial
Secondary Trial Identifying Number
ALL-HEART
Website
http://allheartstudy.org
Study Funded By
National Institute of Health Research (NIHR) Heath Technology Assessment Programme (HTA) Ref: 11/36/41
Funder Type
Sorry, this information is not available
Study Sponsored By
The University of Dundee (UK)
Study Also Sponsored By
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Primary Sponsor Type
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Secondary Sponsor Type
Sorry, this information is not available
Key Dates

Date of First Enrollment

01 Sep 2013

Recruitment End Date

31 May 2019

Trial End Date

31 May 2019

Date added to Registry

16 Aug 2013

Last Updated

16 Aug 2013