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Cardiovascular Drugs and Therapy
Published in: Cardiovascular Drugs and Therapy 6/2022

25-08-2021 | Colchicine | Trial Designs

Assessing the Impact of Colchicine on Coronary Plaque Phenotype After Myocardial Infarction with Optical Coherence Tomography: Rationale and Design of the COCOMO-ACS Study

Authors: Nicholas J. Montarello, Kuljit Singh, Ajay Sinhal, Dennis T. L. Wong, Richard Alcock, Sharmalar Rajendran, Rustem Dautov, Peter Barlis, Sanjay Patel, Stefan M. Nidorf, Peter L. Thompson, Thalia Salagaras, Julie Butters, Nitesh Nerlekar, Giuseppe Di Giovanni, Juanita L. Ottaway, Stephen J. Nicholls, Peter J. Psaltis

Published in: Cardiovascular Drugs and Therapy | Issue 6/2022

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Abstract

Introduction

Recurrent event rates after myocardial infarction (MI) remain unacceptably high, in part because of the continued growth and destabilization of residual coronary atherosclerotic plaques, which may occur despite lipid-lowering therapy. Inflammation is an important contributor to this ongoing risk. Recent studies have shown that the broad-acting anti-inflammatory agent, colchicine, may reduce adverse cardiovascular events in patients post-MI, although the mechanistic basis for this remains unclear. Advances in endovascular arterial wall imaging have allowed detailed characterization of the burden and compositional phenotype of coronary plaque, along with its natural history and responsiveness to treatment. One such example has been the use of optical coherence tomography (OCT) to demonstrate the plaque-stabilizing effects of statins on both fibrous cap thickness and the size of lipid pools within plaque.

Methods

The Phase 2, multi-centre, double-blind colchicine for coronary plaque modification in acute coronary syndrome (COCOMO-ACS) study will evaluate the effect of colchicine 0.5 mg daily on coronary plaque features using serial OCT imaging in patients following MI. Recruitment for the trial has been completed with 64 participants with non-ST elevation MI randomized 1:1 to colchicine or placebo in addition to guideline recommended therapies, including high-intensity statins. The primary endpoint is the effect of colchicine on the minimal fibrous cap thickness of non-culprit plaque over an 18-month period.

Summary

The COCOMO-ACS study will determine whether addition of colchicine 0.5 mg daily to standard post-MI treatment has incremental benefits on high-risk features of coronary artery plaques. If confirmed, this will provide new mechanistic insights into how colchicine may confer clinical benefits in patients with atherosclerotic cardiovascular disease.

Trial Registration

ANZCTR trial registration number: ACTRN12618000809235. Date of trial registration: 11th of May 2018.
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Metadata
Title
Assessing the Impact of Colchicine on Coronary Plaque Phenotype After Myocardial Infarction with Optical Coherence Tomography: Rationale and Design of the COCOMO-ACS Study
Authors
Nicholas J. Montarello
Kuljit Singh
Ajay Sinhal
Dennis T. L. Wong
Richard Alcock
Sharmalar Rajendran
Rustem Dautov
Peter Barlis
Sanjay Patel
Stefan M. Nidorf
Peter L. Thompson
Thalia Salagaras
Julie Butters
Nitesh Nerlekar
Giuseppe Di Giovanni
Juanita L. Ottaway
Stephen J. Nicholls
Peter J. Psaltis
Publication date
25-08-2021
Publisher
Springer US
Published in
Cardiovascular Drugs and Therapy / Issue 6/2022
Print ISSN: 0920-3206
Electronic ISSN: 1573-7241
DOI
https://doi.org/10.1007/s10557-021-07240-9

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