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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colchicine | Active Comparator | 0.5 milligram (mg) per day of Colchicine orally administered over the period of 52 weeks |
|
| Placebo | Placebo Comparator | 0.5mg per day of Placebo orally administered over the period of 52 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colchicine 0.5 MG | Drug | 0.5mg per day of Colchicine orally administered |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 12 months |
| Effects of Colchicine on Pericoronary Adipose Tissue (PCAT) volume using CTA |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Budoff, MD | The Lundquist Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center | Torrance | California | 90502 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41670023 | Derived | Budoff MJ, Bhandari M, Iskander B, Ghanem AK, Kinninger A, Stark J, Garikapati V, Chilukuri S, Hankil V, Krishnan S, Punnanithinont N, Ichikawa K, Kambalapalli S, Hamal S, Lakshmanan S. Effect of colchicine on progression of known coronary atherosclerosis in patients with stable coronary artery disease: EKSTROM randomized placebo controlled trial. Eur Heart J Cardiovasc Imaging. 2026 Mar 27;27(4):682-692. doi: 10.1093/ehjci/jeag028. | |
| 39029568 |
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Double blind Placebo controlled
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To determine the effects of Colchicine on PCAT volume. |
| 12 months |
| Effects of Colchicine on Epicardial Adipose Tissue (EAT) volume using CTA | To determine the effects of Colchicine on EAT volume. | 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. | 12 months |
| Derived |
| Verghese D, Hamal S, Ghanem A, Kinninger A, Javier D, Ichikawa K, Benzing T, Krishnan S, Kianoush S, Hamidi H, Bagheri M, Abraham D, Deljavanghodrati M, Ghoto A, Aldana-Bitar J, Budoff M. Effect of colchicine on progression of known coronary atherosclerosis in patients with STable CoROnary artery disease CoMpared to placebo (EKSTROM) trial-rationale and design. Am Heart J. 2024 Nov;277:20-26. doi: 10.1016/j.ahj.2024.07.005. Epub 2024 Jul 17. |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D003078 | Colchicine |
| ID | Term |
|---|---|
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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