Overview

Colchicine in Decrease of Perivascular Inflammation Index on Coronary CTA: A Randomized Open-label Trial

Status:
Recruiting
Trial end date:
2025-03-07
Target enrollment:
0
Participant gender:
All
Summary
Evaluate the effectiveness of colchicine in reducing coronary perivascular inflammation in patients with documented atherosclerosis and coronary inflammation after 12 months of the use 0.5mg dose once a day in patients undergoing elective coronary CT angiography
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Sao Paulo General Hospital
Treatments:
Colchicine
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 in the proximal segment
of the right and/or anterior descending coronary artery with high FAI value (> -70.1
HU)

- 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