NCT05347316

Colchicine Effect on Perivascular Inflammation Index on Coronary CTA

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Sao Paulo General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Atherosclerosis
• Inflammatory Response
• Coronary Disease

Interventions

Type	Name	Description
DRUG	Colchicine	0.5 mg per day colchicine for 12 months

Timeline

• Start date: 2022-03-07
• Primary completion: 2023-03-07
• Completion: 2025-03-07
• First posted: 2022-04-26
• Last updated: 2022-05-09

Locations

1 site across 1 country: Brazil