Research Information Sheet for Practices
Study Title / All - HEARTSponsor / University of Dundee
Funders / National Institute For Health Research (NIHR)
Chief Investigator / Dr Isla Mackenzie
Study design / The study is a multi-centre, controlled, prospective randomised open-label blinded endpoint (PROBE) trial of allopurinol 600mg daily vs no treatment added to usual therapy in patients aged 60 years and over with ischaemic heart disease (IHD).
Primary Study Aim & Objectives / To study patients aged 60 years and over with IHD in the UK.
Primary Objective
To determine if the addition of allopurinol 600mg daily to usual therapy improves cardiovascular outcomes.
Secondary Objectives
To determine the cost-effectiveness of adding allopurinol 600mg daily to usual therapy.
To determine if the addition of allopurinol 600mg daily to usual therapy improves quality of life assessed by:
1. General health survey (EQ-5D)
2. Coronary heart disease-specific questionnaire (Seattle Angina Questionnaire)
To determine the safety and tolerability of giving allopurinol to patients with IHD
Practice target & study duration / 15 patients per practice
Recruitment period / Until 2019
Summary of Eligibility Criteria (refer to Protocol for full criteria) / Main Inclusion Criteria
1. Male or female patients aged 60 yrs and over
2. Ischaemic heart disease (IDH) defined as a diagnosis of angina or myocardial infarction (MI) at any time or other evidence of ischaemic heart disease (investigator opinion)
Main Exclusion Criteria
1. History of gout
2. If patients have a history of an eGFR <30 ml/min anywhere in their medical record
or if their baseline eGFR result comes back as <30 ml/min, they will be excluded
from the study
3. If a patient’s baseline eGFR is between 30 and 60 ml/min, they will only be
uptitrated to 300mg of allopurinol (not 600mg)
4. If a patient’s baseline eGRF is >60 ml/min, they will be titrated up to 600mg of
allopurinol as usual
5. Moderate to severe heart failure (NYHA III-IV).
6. Significant hepatic disease (eg ALT >3 x upper limit of normal, cirrhosis, ascites) (investigator opinion)
7. 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).
8. Previous allergy to allopurinol
9. 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)
10. Patients already taking urate lowering therapy (including allopurinol, febuxostat, sulfinpyrazone, benzbromarone, probenecid, rasburicase).
11. Patients taking azathioprine, mercaptopurine, ciclosporin or theophylline.
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).
Core Practice Activities / · Prepare and conduct a search on their GP system
· Check list for exclusion
· Practice/Research Nurse to conduct baseline and 6 week follow up visits
· 1 year follow up of patient (see flowchart for details)
Patient Involvement / · 2 practice based visits (Baseline and 6 week follow up)
· 1 year follow up of patient (see flowchart for details)
Resources provided by the study team / Reimbursement for this study is £400.40*
Research nurse will be provided
*Amount is an indication and can vary depending on number of patients entered into the study from your practice.
Local CRN contacts: Saif Uddin 0121 414 8614
Version 2.1 13April2016 All Heart RISP Page 2 of 3
STUDY FLOW CHART
Version 2.1 13April2016 All Heart RISP Page 2 of 3