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

当前位置： X-MOL 学术 › Cardiovasc. Drugs Ther. › 论文详情

Our official English website, www.x-mol.net, welcomes your feedback! (Note: you will need to create a separate account there.)

Assessing the Impact of Colchicine on Coronary Plaque Phenotype After Myocardial Infarction with Optical Coherence Tomography: Rationale and Design of the COCOMO-ACS Study
Cardiovascular Drugs and Therapy ( IF 3.1 ) Pub Date : 2021-08-25 , DOI: 10.1007/s10557-021-07240-9
Nicholas J Montarello ₁ , Kuljit Singh ₂ , Ajay Sinhal ₃ , Dennis T L Wong ₄ , Richard Alcock ₅ , Sharmalar Rajendran ₆ , Rustem Dautov ₇ , Peter Barlis ₈ , Sanjay Patel ₉ , Stefan M Nidorf _{10,

11} , Peter L Thompson _{10,

11,

12} , Thalia Salagaras ₁₃ , Julie Butters _{4,

13} , Nitesh Nerlekar _{4,

14} , Giuseppe Di Giovanni ₁₃ , Juanita L Ottaway ₁₃ , Stephen J Nicholls ₄ , Peter J Psaltis _{1,

13,

15}

Affiliation

Department of Cardiology, Central Adelaide Local Health Network, Adelaide, Australia.
Department of Cardiology, Gold Coast University Hospital, Gold Coast, Australia.
Flinders Medical Centre, Flinders University, Adelaide, Australia.
Victorian Heart Institute, Monash University, Clayton, Australia.
Royal Perth Hospital, Perth, Australia.
Lyell McEwin Hospital, Adelaide, Australia.
The Prince Charles Hospital, Brisbane, Australia.
The Northern Hospital, Melbourne, Australia.
Royal Prince Alfred Hospital, Sydney, Australia.
GenesisCare Western Australia, Perth, Australia.
Heart and Vascular Research Institute of Western Australia, Perth, Australia.
Sir Charles Gairdner Hospital, Perth, Australia.
South Australian Health and Medical Research Institute, PO Box 11060, Adelaide, SA, 5001, Australia.
Baker Heart and Diabetes Institute, Melbourne, Australia.
Adelaide Medical School, University of Adelaide, Adelaide, Australia.

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.

中文翻译：

使用光学相干断层扫描评估秋水仙碱对心肌梗死后冠状动脉斑块表型的影响：COCOMO-ACS 研究的基本原理和设计

介绍

心肌梗死 (MI) 后的复发事件率仍然高得令人无法接受，部分原因是残留的冠状动脉粥样硬化斑块持续生长和不稳定，尽管进行了降脂治疗，但仍可能发生这种情况。炎症是造成这种持续风险的重要因素。最近的研究表明，广效抗炎药秋水仙碱可以减少 MI 后患者的不良心血管事件，尽管其机制基础仍不清楚。血管内动脉壁成像技术的进步可以详细描述冠状动脉斑块的负荷和组成表型，以及其自然病程和对治疗的反应。

方法

2 期多中心双盲秋水仙碱用于急性冠状动脉综合征冠状动脉斑块修饰 (COCOMO-ACS) 研究将使用连续 OCT 成像评估 MI 后患者每日 0.5 mg 秋水仙碱对冠状动脉斑块特征的影响。该试验的招募已经完成，64 名患有非 ST 段抬高 MI 的参与者除了接受指南推荐的治疗（包括高强度他汀类药物）外，还按照 1:1 的比例随机分配接受秋水仙碱或安慰剂。主要终点是秋水仙碱在 18 个月内对非罪犯斑块最小纤维帽厚度的影响。