Ischaemic heart disease (IHD) Circulatory System Ischaemic heart disease
Conditions
Interventions
Interventions as of 04/04/2016:
Patients are randomised to two groups:
1. Receive standard care plus allopurinol (600 mg daily) (Allopurinol dose will be lower at 300mg daily in those patients with mi
Sponsors
The University of Dundee (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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)
Exclusion criteria
Exclusion criteria: 1. History of gout 2. Known severe renal impairment (eGFR 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite (APTC) CV endpoint of non-fatal myocardial infarction (MI), non-fatal stroke and CV death is determined by record-linkage supported by information from medical records | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 The secondary outcome measures 1-9 will primarily be determined by record-linkage supported by information from medical records. Quality of life is assessed by EQ-5D and Seattle Angina Questionnaires at 0, 1 and 5 years. The cost-effectiveness analysis is supported by information from service usage questionnaires at 1 and 5 years and additionally at 2, 3 and 4 years in a 25% sample of the study population. | — |
Countries
England, Scotland, United Kingdom
Outcome results
None listed