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Clinical Trials/ACTRN12620001185954
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

Fiona Stanley Hospital0 sites28 target enrollmentStarted: November 9, 2020Last updated:
Conditions

Trial Snapshot

Phase
Phase 3
Status
Not yet recruiting
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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