This is a randomized double-blind, placebo-controlled, investigator-initiated trial that compares Colchicine 0.5mg/day with placebo, among patients with stable CAD. Subjects will be educated to maintain medication compliance with other prescribed medications.
The goal of this study is to evaluate whether treatment with Colchicine results in greater change of low attenuation plaque volume from baseline level when compared to placebo in subjects with stable Coronary Artery Disease (CAD). The Primary objective of the study is to determine progression rates of low attenuation plaque under influence of Colchicine as compared to placebo. The study will also look to determine effects of Colchicine on the morphology and composition non -calcified coronary plaque, progression of total plaque volume, progression of high vulnerability features of plaque and to assess whether these effects are modulated by a change in HsCRP and other markers of inflammation (HsCRP, IL-6, IL-1α, IL-1β, IL-18) as well as the effect on Pericoronary adipose tissue (PCAT) and Epicardial adipose tissue (EAT) volume and well as on the endothelial function.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE
Enrollment
84
0.5mg per day of Colchicine orally administered
Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center
Torrance, California, United States
Rate of change in low attenuation plaque volume as measured by multidetector computed tomography (MDCT) angiography
Reduction of low attenuation plaque volume from baseline (start of the study) till the final visit will be measured using Coronary Computed Tomography Angiography (CTA).
Time frame: 12 months
Effect of Colchicine on markers of inflammation using laboratory tests
To determine the effect of Colchicine on markers of inflammation (IL-6, IL-1α, IL-1β, IL-18 high sensitivity C-reactive protein)
Time frame: 12 months
Effects of Colchicine on Pericoronary Adipose Tissue (PCAT) volume using CTA
To determine the effects of Colchicine on PCAT volume.
Time frame: 12 months
Effects of Colchicine on Epicardial Adipose Tissue (EAT) volume using CTA
To determine the effects of Colchicine on EAT volume.
Time frame: 12 months
Effect of Colchicine on the markers of Endothelial Function using Flow-mediated dilation (FMD)
To determine the effect of Colchicine on Endothelial function using FMD.
Time frame: 12 months
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