Colchicine Effect on Perivascular Inflammation Index on Coronary CTA

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-07

Study Completion Date

2025-03-07

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.

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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.

Conditions

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Atherosclerosis Inflammatory Response Coronary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Colchicine

0.5 mg of colchicine daily for 12 months

Group Type EXPERIMENTAL

Colchicine

Intervention Type DRUG

0.5 mg per day colchicine for 12 months

Placebo

Follow-up for 12 months

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Colchicine

0.5 mg per day colchicine for 12 months

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No