Colchicine Effect on Perivascular Inflammation Index on Coronary CTA (COPIX)

University of Sao Paulo General Hospital

Status and phase

Enrolling

Phase 1

Conditions

Inflammatory Response

Coronary Disease

Atherosclerosis

Treatments

Drug: Colchicine

Study type

Interventional

Funder types

Other

Identifiers

NCT05347316

SDC 5327/21/102

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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