Colchicine Effect on Perivascular Inflammation Index on Coronary CTA

Study Overview
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Brief Summary
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Inflammation is an important pillar of atherogenesis in coronary disease. Studies have documented the prognostic power of measuring coronary perivascular adipose tissue attenuation (PVAT) and its good correlation as an early inflammatory biomarker in the atherogenesis process, in addition to being a predictor for cardiovascular events in the future. Colchicine, a medication with well-documented anti-inflammatory action and with an impact on reducing cardiovascular outcomes, may have an action in reducing FAI (fat attenuation index). This study aims to evaluate the effect of colchicine in reducing coronary perivascular inflammation.

Detailed Description
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A single-center, prospective, single-blind randomized study to evaluate the efficacy of colchicine versus placebo in patients with documented FAI ≥ -70.1 HU of the proximal segment of the right coronary artery and/ou left anterior descending coronary artery and non-calcified or mixed plaques on coronary angiography performed electively after 12-month follow-up.

Official Title
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Colchicine Effect on Perivascular Inflammation Index on Coronary CTA(COPIX Trial)

Conditions
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Atherosclerosis, Inflammatory Response, Coronary Disease

Intervention / Treatment
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* Drug: Colchicine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals of both sexes over 18 years of age; Patients undergoing coronary CT angiography from May/2021 CT angiography showing non-calcified or mixed coronary plaques and high FAI value (> -70.1 HU) in the proximal segment of the right and/or anterior descending coronary artery with Willing and able (in the opinion of the investigators) to fulfill all study requirements Exclusion Criteria: Past history of acute myocardial infarction History of percutaneous or surgical myocardial revascularization History of previous cardiac surgery or congenital heart disease Current use of colchicine Autoimmune disease requiring immunosuppressive therapy or current use of systemic corticosteroid therapy Active neoplasm with indication of surgery, chemotherapy or radiation in the last 12 months (patients with a history of neoplasm and who underwent curative surgery without need for treatment in the last 12 months will be allowed) Inflammatory bowel disease or chronic diarrhea Clinically significant non-transient hematologic abnormalities Renal dysfunction (GFR < 30 mL/min/1.73 m² and/or serum creatinine > 2.5 mg/dL or < 220 µmol/l) Severe liver disease (aspartate aminotransferase [AST] or alanine aminotransferase [ALT] > 3x ULN in the last 6 months) Drug addiction or alcoholism History of clinically significant sensitivity to colchicine Inability to sign the informed consent form Participation in another study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Colchicine<br>0.5 mg of colchicine daily for 12 months | Drug: Colchicine<br>* 0.5 mg per day colchicine for 12 months<br>|
| No Intervention: Placebo<br>Follow-up for 12 months | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification of FAI in both groups after 12-month follow-up |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the variation total atheroma volume |  | 12 months | 
| Evaluation of low attenuation plate volume variation; |  | 12 months | 
| Occurrence of general death |  | 12 months | 
| Occurrence of cardiovascular death |  | 12 months | 
| Occurrence of acute myocardial infarction |  | 12 months | 
| Occurrence of stroke |  | 12 months | 
| Occurrence of need for myocardial revascularization |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Perivascular adipose tissue attenuation, Fat attenuation index, Colchicine, Coronary disease, Inflammation