COPIX: Colchicine Effect on Perivascular Inflammation Index on Coronary CTA

Sponsor

University of Sao Paulo General Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05347316

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atherosclerosis Inflammatory Response Coronary Disease	Drug: Colchicine	Phase 1

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 7, 2022

Anticipated Primary Completion Date :

Mar 7, 2023

Anticipated Study Completion Date :

Mar 7, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Colchicine 0.5 mg of colchicine daily for 12 months	Drug: Colchicine 0.5 mg per day colchicine for 12 months
No Intervention: Placebo Follow-up for 12 months

Arm

Intervention/Treatment

Experimental: Colchicine

0.5 mg of colchicine daily for 12 months

Drug: Colchicine

0.5 mg per day colchicine for 12 months

No Intervention: Placebo

Follow-up for 12 months

Outcome Measures

Primary Outcome Measures

Quantification of FAI in both groups after 12-month follow-up [12 months]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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