Research Information Sheet for Practices

Study Title	FAST - Febuxostat versus Allopurinol Streamlined Trial
Sponsor	University of Dundee
Funders	This is an academically led non-commercial trial that is funded by Menarini International Operations Luxembourg SA
Chief Investigator	Prof Tom MacDonald, Ninewells Hospital and Medical School
Study design	A prospective, randomised, open-label, blinded endpoint (PROBE) clinical trial
Primary Study Aim & Objectives	To compare the cardiovascular (CV) safety profile (in terms of Anti Platelet Trialists’ Collaboration [APTC] events) of febuxostat versus allopurinol when taken for an average of 3 years in patients aged 60 years or older with chronic hyperuricaemia in conditions where urate deposition has already occurred. The secondary study objectives are to evaluate other cardiovascular adverse events for both products.
Practice target & study duration	Approximately 6 patients per practice dependent on list size. 3-5 years duration for each patient
Recruitment period	November 2014 to July 2016 (inclusive)
Summary of Eligibility Criteria (refer to Protocol for full criteria)	Males & females aged >60 yrs At least one additional cardiovascular risk factor Require treatment for chronic hyperuricaemia where urate deposition has already occurred Have received more than 60 days treatment with allopurinol or more than 2 prescriptions within the previous 6 months Exclude patients with severe renal impairment, a life threatening co-morbidity, congestive heart failure, a current gout flare up or those who have had an MI or stroke within the previous six months
Core Practice Activities	Run a database search in line with the inclusion/ exclusion criteria. GP to check list of identified patients and remove any inappropriate patients Mail merge the identified list with the practice-headed patient invitation letter and mail to identified patients ( study team will provide prepaid envelopes and prepaid reply slips ) Provision of suitable clinic room for patient visits Provide access to patient records for monitoring visits Assistance with blood test as appropriate Reporting of serious adverse events (hospitals admissions / deaths) via an easy-to-use web portal
Patient Involvement	Attendance at surgery with Research Nurse for consent, health check, blood test. If urate level is more than 6 mg/dL, Allopurinol dose increased / titrated until correct level achieved and monitored every 2-3 weeks by Research Nurse. Patient is randomised to either receive Allopurinol or Febuxostat. 2 monthly follow up of patient by phone, email, letter or visit by Research Nurse Annual blood tests with research nurse
Resources provided by the study team	Study team will provide each participating practice all resources for the mail out, a study Site File and will update practices with any study amendments for the study duration Trial specific research nurses with assistance from local CRN research nurses

Local CRN contacts: Tracey Adcock T.A.Adcock@warwick.ac.uk 07880175385

Jenny Lee Jennifer.Lee@warwick.ac.uk 02476 575919

STUDY FLOW CHART

Identification of eligible patients via clinical system search. Invitation mail out to appropriate patients. Study team liaise with the practice team re available clinic times Patient response to study team who arrange screening visit Patient attends screening visit with research nurse to obtain consent, medical history and blood samples Allopurinol dose optimised (if required) posted out to patient Randomisation by telephone One week washout period where new medication and gout prophylaxis is posted out to patient Febuxostat After 2 weeks blood sample taken to check dose is correct. Research Nurse contact every 2 months. Blood sample at 12 months to check uric acid levels Allopurinol Research Nurse contact with patient every 2 months Blood sample after 12 months to check uric acid levels