Effect of anakinra therapy on cardiovascular risk in acute gout patient

Phase 3

• Conditions: Gout; Cardiovascular disease; Musculoskeletal - Other muscular and skeletal disorders; Cardiovascular - Coronary heart disease

• Registration Number: ACTRN12620001185954
• Lead Sponsor: Fiona Stanley Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-09
• Last Update Posted: 16 November 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified