Allopurinol and cardiovascular outcomes in patients with ischaemic heart disease (ALL-HEART)

Conditions: Ischaemic Heart Disease (IHD), angina or myocardial infarction
MedDRA version: 16.0Level: LLTClassification code 10023024Term: Ischaemic heart diseaseSystem Organ Class: 100000004849
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2013-003559-39-GB

Lead Sponsor: The University of Dundee

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 5215

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 of ischaemic heart disease (investigator opinion).

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1000
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4215

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).