Status:
COMPLETED
Effect of Metformin on Carotid Atherosclerosis for Non-diabetic Patients With PsA (CAMPA Study)
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
PsA (Psoriatic Arthritis)
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Background: Psoriatic arthritis (PsA) is a common chronic inflammatory disease with a prevalence up to 670 every 100,000 subjects. Patients with PsA has an increased risk of cardiovascular disease (CV...
Detailed Description
Psoriatic arthritis (PsA) is a common chronic inflammatory disease with a prevalence up to 670 every 100,000 subjects. Patients with PsA has an increased risk of cardiovascular disease (CVD) which is ...
Eligibility Criteria
Inclusion
- fulfill the ClASsification criteria for Psoriatic ARthritis (CASPAR),
- are over 18 years old,
- have a Framingham Risk Score ≥ 10% (i.e. moderate to high CV risk) and
- have carotid plague on previous ultrasound.
Exclusion
- have prior therapy with metformin during the last 6 months;
- have pre-existing diabetes as defined by the World Health Organization (WHO) criteria:
- fasting plasma glucose values of ≥ 7.0 mmol/L,
- 2-h post-load plasma glucose ≥ 11.1 mmol/L,
- HbA1c ≥ 6.5% or
- a random blood glucose ≥ 11.1 mmol/L);
- have liver impairment: ALT more than or equal to 2.5×upper limits of normal;
- have renal impairment: serum creatinine levels more than or equal to 135µmol/L in males and more than or equal to 110µmol/L in females;
- have had ACS within the previous 3 months;
- have New York Heart Association functional class 3 or 4 heart failure;
- have uncontrolled angina;
- have 70% or more stenosis on initial CCTA;
- have clinically relevant current malignancy;
- are pregnant; breastfeeding or of childbearing potential but unwilling to use adequate contraception;
- are unable to give written informed consent;
- patients with moderate to heavy alcohol intake.
Key Trial Info
Start Date :
August 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2025
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT05988684
Start Date
August 30 2023
End Date
September 30 2025
Last Update
November 24 2025
Active Locations (1)
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1
The Chinese University of Hong Kong
Hong Kong, Hong Kong