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Abstract：
BACKGROUND: 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. 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.
BACKGROUND: ANZCTR trial registration number: ACTRN12618000809235. Date of trial registration: 11th of May 2018.
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. 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.
BACKGROUND: ANZCTR trial registration number: ACTRN12618000809235. Date of trial registration: 11th of May 2018.
摘要：
背景：心肌梗死（MI）后的复发事件发生率仍然高得令人无法接受，部分原因是残余冠状动脉粥样硬化斑块的持续增长和不稳定，尽管进行了降脂治疗，但仍可能发生。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，尽管其机制基础尚不清楚。血管内动脉壁成像的进展已经允许对冠状动脉斑块的负荷和组成表型进行详细表征。以及其自然史和对治疗的反应。一个这样的例子是使用光学相干断层扫描（OCT）来证明他汀类药物对斑块内纤维帽厚度和脂质池大小的斑块稳定作用。
方法：第二阶段，多中心，双盲秋水仙碱用于急性冠脉综合征冠脉斑块修饰(COCOMO-ACS)研究将使用连续OCT成像技术评估每日0.5mg秋水仙碱对心肌梗死后患者冠脉斑块特征的影响.除了指南推荐的疗法外，64名非ST段抬高型MI的参与者已完成招募，随机分为1：1，以秋水仙碱或安慰剂。包括高强度他汀类药物。主要终点是秋水仙碱对18个月内非罪犯斑块的最小纤维帽厚度的影响。COCOMO-ACS研究将确定在标准MI后治疗中每天添加0.5mg秋水仙碱是否对冠状动脉斑块的高风险特征具有增量益处。如果确认,这将为研究秋水仙碱如何给动脉粥样硬化性心血管疾病患者带来临床益处提供新的机制.
背景：ANZCTR试验注册号：ACTRN12618000809235。试用登记日期：2018年5月11日。
方法：第二阶段，多中心，双盲秋水仙碱用于急性冠脉综合征冠脉斑块修饰(COCOMO-ACS)研究将使用连续OCT成像技术评估每日0.5mg秋水仙碱对心肌梗死后患者冠脉斑块特征的影响.除了指南推荐的疗法外，64名非ST段抬高型MI的参与者已完成招募，随机分为1：1，以秋水仙碱或安慰剂。包括高强度他汀类药物。主要终点是秋水仙碱对18个月内非罪犯斑块的最小纤维帽厚度的影响。COCOMO-ACS研究将确定在标准MI后治疗中每天添加0.5mg秋水仙碱是否对冠状动脉斑块的高风险特征具有增量益处。如果确认,这将为研究秋水仙碱如何给动脉粥样硬化性心血管疾病患者带来临床益处提供新的机制.
背景：ANZCTR试验注册号：ACTRN12618000809235。试用登记日期：2018年5月11日。
