Clinical trial NCT05347316: Colchicine Effect on Perivascular Inflammation Index on Coronary CTA
Official title: Colchicine Effect on Perivascular Inflammation Index on Coronary CTA(COPIX Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Atherosclerosis
Inflammatory Response
Coronary Disease
Keywords: Perivascular adipose tissue attenuation
Fat attenuation index
Colchicine
Coronary disease
Inflammation
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2022-04-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Quantification of FAI in both groups after 12-month follow-up
timeFrame: 12 months
Secondary outcomes:
measure: Evaluation of the variation total atheroma volume
timeFrame: 12 months
measure: Evaluation of low attenuation plate volume variation;
timeFrame: 12 months
measure: Occurrence of general death
timeFrame: 12 months
measure: Occurrence of cardiovascular death
timeFrame: 12 months
measure: Occurrence of acute myocardial infarction
timeFrame: 12 months
measure: Occurrence of stroke
timeFrame: 12 months
measure: Occurrence of need for myocardial revascularization
timeFrame: 12 months
Other outcomes:
Locations:
city: São paulo
country: Brazil
facility: Heart Institute - University of São Paulo
state: Sao Paulo
Study officials:
References: