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

Primary Purpose

Atherosclerosis, Inflammatory Response, Coronary Disease

Status

Recruiting

Phase

Phase 1

Locations

Brazil

Study Type

Interventional

Intervention

Colchicine

About this trial

This is an interventional treatment trial for Atherosclerosis focused on measuring Perivascular adipose tissue attenuation, Fat attenuation index, Colchicine, Coronary disease, Inflammation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Heart Institute - University of São PauloRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Colchicine

Placebo

Arm Description

0.5 mg of colchicine daily for 12 months

Follow-up for 12 months

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Evaluation of the variation total atheroma volume

Evaluation of low attenuation plate volume variation;

Occurrence of general death

Occurrence of cardiovascular death

Occurrence of acute myocardial infarction

Occurrence of stroke

Occurrence of need for myocardial revascularization

Full Information

NCT ID

NCT05347316

First Posted

April 20, 2022

Last Updated

May 3, 2022

Sponsor

University of Sao Paulo General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05347316

Brief Title

Colchicine Effect on Perivascular Inflammation Index on Coronary CTA

Acronym

COPIX

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Recruiting

Study Start Date

March 7, 2022 (Actual)

Primary Completion Date

March 7, 2023 (Anticipated)

Study Completion Date

March 7, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Sao Paulo General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atherosclerosis, Inflammatory Response, Coronary Disease

Keywords

Perivascular adipose tissue attenuation, Fat attenuation index, Colchicine, Coronary disease, Inflammation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Colchicine

Arm Type

Experimental

Arm Description

0.5 mg of colchicine daily for 12 months

Arm Title

Placebo

Arm Type

No Intervention

Arm Description

Follow-up for 12 months

Intervention Type

Drug

Intervention Name(s)

Colchicine

Intervention Description

0.5 mg per day colchicine for 12 months

Primary Outcome Measure Information:

Title

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

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Evaluation of the variation total atheroma volume

Time Frame

12 months

Title

Evaluation of low attenuation plate volume variation;

Time Frame

12 months

Title

Occurrence of general death

Time Frame

12 months

Title

Occurrence of cardiovascular death

Time Frame

12 months

Title

Occurrence of acute myocardial infarction

Time Frame

12 months

Title

Occurrence of stroke

Time Frame

12 months

Title

Occurrence of need for myocardial revascularization

Time Frame

12 months

10. Eligibility

Sex

All

Gender Based

Yes

Gender Eligibility Description

over 18 years

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

CARLOS SERRANO, Doctor

Phone

+55(11) 26615447

cvserranojr@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Camila Barbosa, Doctor

Phone

+55(11) 986015021

dracamilatalita@gmail.com

Facility Information:

Facility Name

Heart Institute - University of São Paulo

City

São paulo

State/Province

Sao Paulo

ZIP/Postal Code

05403000

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Carlos Serrano, Doctor

Phone

+55 11 2661 5352

cvserranojr@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Colchicine Effect on Perivascular Inflammation Index on Coronary CTA

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