Download RISP - University of Birmingham

Research Information Sheet for Practices
Study Title
Sponsor
Funders
Chief
Investigator
Study design
All - HEART
University of Dundee
National Institute For Health Research (NIHR)
Dr Isla Mackenzie
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).
To study patients aged 60 years and over with IHD in the UK.
Primary Study
Aim & Objectives
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).
Version 2.1 13April2016
All Heart RISP
Page 1 of 3
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
Patient
Involvement




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)


2 practice based visits (Baseline and 6 week follow up)
1 year follow up of patient (see flowchart for details)
Reimbursement for this study is £400.40*
Resources
provided by the
study team
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 [email protected] 0121 414 8614
Version 2.1 13April2016
All Heart RISP
Page 2 of 3
STUDY FLOW CHART
Patient Invite



GP Practice list searched (search codes
available for System1 and EMIS)
GP screens the patient list
Patients are invited via Docmail
Baseline Clinic/Visit
Practice Nurse/Research Nurse:
1) takes informed consent
2) inclusion & exclusion criteria checked
3) blood samples taken (for baseline blood count,
urea and electrolytes, creatine, eGFR and urate
4) Nurse completes online eCRF
5) Nurse sends blood to local designated lab
Patient completes 2 short questionnaires
Randomisation




Bloods processed by local lab and
results are uploaded to study team CRF
website
eGFR needs to be 30 or more to be
eligible.
Nurses access the study team website for results
(before randomisation)
Nurse performs randomisation via online/phone –
Patients are randomised to Allopurinol or no
Allopurinol treatment
Nurse requests GP to prescribe Allopurinol*(if
applicable)
Follow up 6 week clinic (only for patients randomised on
Allopurinol)
Practice Nurse/Research Nurse:

Patient check and repeats bloods (for baseline blood
count urea and electrolytes, creatine, eGFR and urate)
 Nurse completes online eCRF
Patient is asked to report any adverse events
1 Year Follow up
 Nurse to email, write or telephone patient for a 12 month check
 Nurse/GP to record any SAE online
 Patient completes healthcare and end of trial questionnaire
 Record linkage for events will be carried out annually
* GP to prescribe at set frequency - 2wks @100mg, 2wks @300mg, 2wks @600mg then if patient can tolerate 600mg
continue on this to end of study (4yrs). Allopurinol will be started at 100mg daily for 2 weeks, then titrated to 300mg
daily for 2 weeks, then titrated to 600mg daily if tolerated.
Version 2.1 13April2016
All Heart RISP
Page 3 of 3