NCT05347316

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2022

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 7, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 20, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 26, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2025

Completed
Last Updated

May 9, 2022

Status Verified

May 1, 2022

Enrollment Period

1 year

First QC Date

April 20, 2022

Last Update Submit

May 3, 2022

Conditions

AtherosclerosisInflammatory ResponseCoronary Disease

Keywords

Perivascular adipose tissue attenuationFat attenuation indexColchicineCoronary diseaseInflammation

Outcome Measures

Primary Outcomes (1)

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

    12 months

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (2)

Colchicine

EXPERIMENTAL

0.5 mg of colchicine daily for 12 months

Drug: Colchicine

Placebo

NO INTERVENTION

Follow-up for 12 months

Interventions

ColchicineDRUG

0.5 mg per day colchicine for 12 months

Colchicine

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility Detailsover 18 years
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart Institute - University of São Paulo

São Paulo, São Paulo, 05403000, Brazil

RECRUITING

MeSH Terms

Conditions

AtherosclerosisCoronary DiseaseInflammation

Interventions

Colchicine

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesMyocardial IschemiaHeart DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AlkaloidsHeterocyclic Compounds

Central Study Contacts

CARLOS SERRANO, Doctor

CONTACT

+55(11) 26615447cvserranojr@gmail.com

Camila Barbosa, Doctor

CONTACT

+55(11) 986015021dracamilatalita@gmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

April 20, 2022

First Posted

April 26, 2022

Study Start

March 7, 2022

Primary Completion

March 7, 2023

Study Completion

March 7, 2025

Last Updated

May 9, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)