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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Disease; Atherosclerosis; Inflammatory Response
• Intervention / Treatment: Drug: Colchicine

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: CARLOS SERRANO, Doctor; Phone Number: +55(11) 26615447; Email: cvserranojr@gmail.com
• Study Contact Backup: Name: Camila Barbosa, Doctor; Phone Number: +55(11) 986015021; Email: dracamilatalita@gmail.com

Study Locations

• Brazil
  • Sao Paulo
    • São paulo, Sao Paulo, Brazil, 05403000
      • Recruiting
      • Heart Institute - University of São Paulo
      • Contact: Carlos Serrano, Doctor; Phone Number: +55 11 2661 5352; Email: cvserranojr@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 7, 2022
• Primary Completion (ANTICIPATED): March 7, 2023
• Study Completion (ANTICIPATED): March 7, 2025

Study Registration Dates

• First Submitted: April 20, 2022
• First Submitted That Met QC Criteria: April 20, 2022
• First Posted (ACTUAL): April 26, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 9, 2022
• Last Update Submitted That Met QC Criteria: May 3, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Inflammation; Colchicine; Coronary disease; Perivascular adipose tissue attenuation; Fat attenuation index
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Coronary Disease; Inflammation; Atherosclerosis; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Gout Suppressants; Colchicine
• Other Study ID Numbers: SDC 5327/21/102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No