EUCTR2011-001883-23-FIActive, not recruitingPhase 1
FAST- Febuxostat versus Allopurinol Streamlined Trial A prospective, randomised, open-label, blinded endpoint (PROBE) clinical trial evaluating long term cardiovascular safety of febuxostat in comparison with allopurinol in patients with chronic symptomatic hyperuricaemia - FAST- Febuxostat versus Allopurinol Streamlined Trial
niversity of Dundee0 sites5,706 target enrollmentStarted: June 6, 2016Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 5,706
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Male or female patients aged 60 years or older with at least one additional cardiovascular risk factor: Age =70 years (male) or =75 years (female); Smoking (current or within the last 2 years); Diabetes mellitus; Impaired glucose tolerance; Hypertension (SBP >140 mmHg and/or DBP >90 mmHg) or receiving treatment to lower blood pressure; Dyslipidaemia (investigator assessment); Chronic kidney disease (CKD); Microalbuminuria or proteinuria; Family history of coronary heart disease or stroke in first degree relative at age <55 years; Inflammatory arthritis (investigator assessment – including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis); Chronic NSAID therapy (investigator assessment); Previous cardiovascular (CV) event (MI, cerebrovascular accident [CVA] or transient ischaemic attack [TIA]); Peripheral vascular disease (investigator / clinical assessment); Chronic obstructive pulmonary disease (COPD); Body mass index >30 kg/m2.
- •2. Patients who, in the opinion of the recruiting physician, require treatment for chronic hyperuricaemia where urate deposition has already occurred (including a history or presence of tophus and/or gouty arthritis) fulfilling the recommendation for treatment with urate lowering therapy.
- •3. Patients who have received =60 days treatment with allopurinol, or =2 allopurinol prescriptions, within the previous 6 months.
- •4. Patients, who in the opinion of the recruiting physician or study site coordinator, are eligible for treatment (with reference to the summary of product characteristics) with either allopurinol or febuxostat.
- •5. Patients who are willing to give permission for their paper and electronic medical records, hospitalisation data, prescribing data, and (in the event of their death) their death certification data to be accessed and abstracted by trial investigators.
- •6. Patients who are willing to be contacted and interviewed by trial investigators or delegates (suitably trained research nurses), should the need arise (e.g., for adverse event [AE] assessment and to determine whether an episode of acute gout has occurred).
- •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 3804
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1902
Exclusion Criteria
- •1. Patients who have any contraindication to febuxostat or allopurinol (with reference to the summary of product characteristics) or any of the components of their formulations.
- •2. Patients who are not receiving allopurinol as ULT.
- •3. Patients with severe renal impairment (eGFR <30 mL/min as defined by the Cockroft-Gault formula (http://www.nephron.com/cgi-bin/CGSI.cgi) according to creatinine, age, sex and body weight).
- •4. Patients with moderate or severe hepatic impairment i.e. cirrhosis with clinical and/or biological decompensation (i.e. alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3x reference value, ascites, lower limb oedema, icterus or increased prothrombin time >2x reference value).
- •5. Patients with a life-threatening co-morbidity or with a significant medical condition and/or conditions that would interfere with the treatment, safety or compliance with the protocol.
- •6. Patients with a diagnosis of, or receiving treatment for malignancy (excluding minor skin cancer and indolent cancers that are not thought to be life threatening and require no treatment) in the previous 5 years. (Investigator opinion)
- •7. Patients who have experienced either a myocardial infarction or stroke within the 6 months prior to the screening visit.
- •8. Patients with congestive heart failure, New York Heart Association (NYHA) Class III or IV.
- •9. Patients whose behaviour or lifestyle would render them less likely to comply with study medication (i.e., abuse of alcohol, substance misuse, debilitating psychiatric conditions or inability to provide informed consent).
- •10. Patients with a current acute gout flare or who are within 14 days of the resolution of a gout flare.
- •11. Patients currently participating in another clinical trial or who have participated in a non-interventional clinical trial in the previous 1 month or an interventional clinical trial in the previous 3 months.
Investigators
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