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