None listed
Conditions
Brief summary
The CHARISMA trial is a prospective double-blind, placebo-controlled randomised study to evaluate the effect of adding colchicine to standard medical therapy in patients who have non-obstructive but high-risk plaques in their coronary arteries as demonstrated on cardiac CT angiogram (CCTA). A total of 100 participants will be recruited over the study period. Participants will be randomised to either 1) standard medical therapy or 2) standard therapy plus colchicine 0.5mg daily for 12 months. At the end of 12 months, all participants will then undergo a repeat CCTA. We hypothesise that the addition of colchicine to standard medical therapy will have demonstrate a reduction in markers of coronary inflammation as assessed by peri-coronary adipose tissue attenuation.
Interventions
Participants will receive oral colchicine 0.5mg tablets daily for 12 month in addition to the standard medical therapy (statin +/- aspirin) for nonobstructive coronary artery disease.
Medication adherence will be assessed indirectly by pill counts. Participants will be asked to count the number of pills remain in their medication bottles during scheduled review at month 1, 3, 6, 9, and 12.
Sponsors
Monash Cardiovascular Research Centre, Monash Medical Centre
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Participants who undergo clinically indicated coronary CT angiogram (CCTA) which subsequently demonstrated one or more high-risk plaques (HRP). HRP features includes any of the following: 1) positive remodelling 2) low attenuation plaque (LAP) 3) spotty calcification or 4) ‘napkin ring’ sign. 2. Participants able to provide written informed consent before baseline angiography. 3. Male or female, aged between 18 and 80 years of age at screening. 4. Participants able to be randomised within seven days of CCTA. 5. Baseline CCTA imaging determined to be of acceptable quality.
Exclusion criteria
1. Left main coronary disease (> 50% reduction in lumen diameter by angiographic visual estimation). 2. Heart failure (New York Heart Association (NYHA) class IV) or LVEF 35% or less. 3. Participants with known gout within the last 5 years. 4. Currently prescribed colchicine for other indication, presence of contraindications to colchicine, known prior intolerance to colchicine. Concomitant therapy with drugs that could interact with colchicine (eg strong CYP3A4). 5. Dialysis or estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m². 6. Thyroid stimulating hormone (TSH) < lower limit of normal (LLN) or >1.5x upper limit of normal (ULN). 7. Active liver disease or hepatic dysfunction, or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 times the ULN as determined by analysis at screening. 8. Known major active infection, or major haematologic, renal, metabolic, gastrointestinal, or endocrine dysfunction. 9. Significant haematological abnormalities on assessment of complete blood picture: Hb <100 g/L, Plt <150x103 /µL, white cell count < 3.5x103 /µL. 10. History of malignancy (except non-melanoma skin cancers, cervical in-situ carcinoma, breast ductal carcinoma in-situ, or stage 1 prostate carcinoma). 11. Female participants cannot be pregnant or breast feeding, and premenopausal participants must be willing to use at least 2 highly effective method of birth control during treatment and for an additional 12 weeks after the end of treatment. 12. Unable to give informed consent. 13. Not willing or able to attend follow up visits or follow up CCTA at 6 months. 14. Any other information that the investigator considers will limit the ability of the participant to complete all study associated procedures.
Outcome results
None listed