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Status unknownNCT05347316COPIXUpdated May 9, 2022

Colchicine Effect on Perivascular Inflammation Index on Coronary CTA

A Phase 1 interventional study of Colchicine in Atherosclerosis, Inflammatory Response and Coronary Disease, sponsored by University of Sao Paulo General Hospital. Status unknown at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-09.

Sponsored by University of Sao Paulo General Hospital · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Atherosclerosis
  • Inflammatory Response
  • Coronary Disease

Keywords

  • Perivascular adipose tissue attenuation
  • Fat attenuation index
  • Colchicine
  • Coronary disease
  • Inflammation
03

In context

Atherosclerosis

1,567 studies on the registry are indexed under Atherosclerosis; 265 are open to participants now.

This study's planned enrollment of 40 is below the median of 106 across 882 interventional studies indexed under Atherosclerosis.

Browse Atherosclerosis studies →

Lead sponsor

University of Sao Paulo General Hospital is the lead sponsor of 595 studies on the registry; 98 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Colchicine

    0.5 mg of colchicine daily for 12 months

    Drug: Colchicine

  • No intervention
    Placebo

    Follow-up for 12 months

Interventions

  • DrugColchicine

    0.5 mg per day colchicine for 12 months

06

What researchers measure

Primary outcomes

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

    Time frame: 12 months

Secondary outcomes

  1. Evaluation of the variation total atheroma volume

    Time frame: 12 months

  2. Evaluation of low attenuation plate volume variation;

    Time frame: 12 months

  3. Occurrence of general death

    Time frame: 12 months

  4. Occurrence of cardiovascular death

    Time frame: 12 months

  5. Occurrence of acute myocardial infarction

    Time frame: 12 months

  6. Occurrence of stroke

    Time frame: 12 months

  7. Occurrence of need for myocardial revascularization

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
  • Heart Institute - University of São Paulo
    São paulo, Sao Paulo 05403000, Brazil
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05347316
Lead sponsor
University of Sao Paulo General Hospital
Responsible party
Carlos Vicente Serrano Jr (MD PhD, University of Sao Paulo General Hospital) — Principal investigator
First posted
Apr 26, 2022
Start date
Mar 7, 2022
Primary completion
Mar 7, 2023 (estimated)
Completion
Mar 7, 2025 (estimated)
Last update
May 9, 2022

Study contacts

CARLOS SERRANO, Doctor
Contact
cvserranojr@gmail.com
+55(11) 26615447
Camila Barbosa, Doctor
Contact
dracamilatalita@gmail.com
+55(11) 986015021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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