Colchicine Effect on Perivascular Inflammation Index on Coronary CTA

Atherosclerosis Clinical Trial

— COPIX  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05347316
• Other study ID #: SDC 5327/21/102
• Status: Recruiting
• Phase: Phase 1
• Start date: March 7, 2022
• Est. completion date: March 7, 2025

Study information

• Verified date: May 2022
• Source: University of Sao Paulo General Hospital
• Contact: CARLOS SERRANO, Doctor
• Phone: +55(11) 26615447
• Email: cvserranojr[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 7, 2025
• Est. primary completion date: March 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Coronary Disease
• Inflammation
• Inflammatory Response

Intervention

Drug:
• Colchicine
0.5 mg per day colchicine for 12 months

Locations

Country	Name	City	State
Brazil	Heart Institute - University of São Paulo	São paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantification of FAI in both groups after 12-month follow-up		12 months
Secondary	Evaluation of the variation total atheroma volume		12 months
Secondary	Evaluation of low attenuation plate volume variation;		12 months
Secondary	Occurrence of general death		12 months
Secondary	Occurrence of cardiovascular death		12 months
Secondary	Occurrence of acute myocardial infarction		12 months
Secondary	Occurrence of stroke		12 months
Secondary	Occurrence of need for myocardial revascularization		12 months