Assessing the Impact of Colchicine on Coronary Plaque Phenotype After Myocardial Infarction with Optical Coherence Tomography: Rationale and Design of the COCOMO-ACS Study
| Autor: | Peter Barlis, Sanjay Patel, Thalia Salagaras, Giuseppe Di Giovanni, Stephen J. Nicholls, Nitesh Nerlekar, Peter L. Thompson, Kuljit Singh, Rustem Dautov, Dennis T.L. Wong, Sharmalar Rajendran, Stefan M. Nidorf, R. Alcock, Peter J. Psaltis, Ajay Sinhal, Nicholas J. Montarello, Juanita L Ottaway, Julie Butters |
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| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
Acute coronary syndrome Trial Designs Myocardial Infarction Coronary Artery Disease Coronary Angiography Placebo chemistry.chemical_compound Double-Blind Method Internal medicine Clinical endpoint medicine Humans Colchicine Pharmacology (medical) Myocardial infarction Acute Coronary Syndrome Inflammation Pharmacology Optical coherence tomography business.industry Fibrous cap General Medicine Guideline medicine.disease Coronary Vessels Lipids Plaque Atherosclerotic Phenotype medicine.anatomical_structure chemistry Cardiology Hydroxymethylglutaryl-CoA Reductase Inhibitors Cardiology and Cardiovascular Medicine business Coronary plaque Tomography Optical Coherence Artery |
| Zdroj: | Cardiovascular Drugs and Therapy |
| ISSN: | 1573-7241 0920-3206 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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