ACTRN12620001185954Not yet recruitingPhase 3
Cardiovascular Risk in Gout and Effect of anti - IL1ß therapy (and usual care) on progression of non-calcified coronary plaque burden (NCB) and high-risk plaques (HRPs) using Cardiac Computer Tomography Angiogram (CCTA) in acute gout
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Fiona Stanley Hospital
- Enrollment
- 28
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 45 Years to o limit (—)
- Sex
- All
Inclusion Criteria
- •A diagnosis of gout according to 2015 ACR criteria and defined clinically as requiring initiation or currently on allopurinol therapy.
- •45 years and a minimum of 2 risk factors, i.e. controlled hypertension, controlled diabetes, controlled dyslipidemia, obesity, age >55 years, smoker <65 years and first degree relative with evidence of atherosclerosis <65 years will be recruited.
- •The above cardiac risk factors ensure patients that are likely to have coronary atherosclerotic plaque on CCTA.
Exclusion Criteria
- •1. Other forms of inflammatory arthritis (especially rheumatoid arthritis and psoriasis). 2. Moderate to severe hepatic impairment 3. Contra indication to allopurinol, especially azathioprine or 6-mercaptopurine use. 4. Contra indication to anti IL-1 therapy, including active infection (HIV, tuberculosis, hepatitis B or C). 5. Pregnancy or breastfeeding. 6. Presence of any serious medical illness that may preclude follow up. 7. Inability to provide informed consent. 8. eGFR less than 50. 9. Cardiac stents in situ or coronary artery bypass grafts (CABG). 10. Poorly controlled diabetes. 11. Current malignancy.
Investigators
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