与安慰剂相比,秋水仙碱对稳定型冠状动脉疾病患者已知冠状动脉粥样硬化进展的影响(EKSTROM)试验--原理与设计。

IF 3.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS American heart journal Pub Date : 2024-07-17 DOI:10.1016/j.ahj.2024.07.005
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引用次数: 0

摘要

背景:心血管疾病是美国人死亡的主要原因。尽管改变了生活方式并控制了传统的风险因素,但残留的炎症风险仍是一个未得到治疗的问题。秋水仙碱是一种口服药物,几十年来一直用于治疗痛风、地中海热和心包炎。在最近的试验中,秋水仙碱被证明可以减少主要的心血管不良事件,但其获益机制仍不清楚。随机、双盲、安慰剂对照 EKSTROM 试验的目的是评估秋水仙碱 0.5 毫克/天对动脉粥样硬化斑块的影响:在获得知情同意后,将招募 84 名参与者,并随访 12 个月。符合条件的患者将按 1:1 的比例随机分配到秋水仙碱 0.5 毫克/天或安慰剂,作为其标准治疗的补充。所有参与者都将在基线和12个月时接受冠状动脉计算机断层扫描(CCTA)检查:截至 2023 年 11 月,该研究的参与人数已达 100%,预计研究将于 2024 年第二季度结束。主要终点是 CCTA 测量的低衰减斑块体积的变化。次要终点包括不同斑块类型体积的变化(包括总动脉粥样斑块体积、非钙化斑块体积、致密钙化斑块体积、重塑指数)、炎症标志物(IL-6、IL-1β、IL-18、hs-CRP)的变化、冠状动脉周围脂肪组织衰减的变化、心外膜脂肪组织体积和衰减的变化以及肱动脉血流介导的扩张的变化:EKSTROM 是首个评估秋水仙碱对斑块进展、冠状动脉周围和心外膜脂肪影响的随机研究。EKSTROM 将为秋水仙碱对心血管系统的机理影响提供重要信息。
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Effect of colchicine on progression of known coronary atherosclerosis in patients with STable CoROnary artery disease CoMpared to placebo (EKSTROM) trial—rationale and design

Background

Cardiovascular disease is the major cause of mortality in the United States. Despite lifestyle modification and traditional risk factor control residual inflammatory risk remains an untreated concern. Colchicine is an oral, medication that has been used for gout, mediterranean fever and pericarditis for decades. In recent trials, colchicine has been shown to reduce major adverse cardiovascular events, however the mechanism of benefit remains unclear. The objective of the randomized, double-blind, placebo controlled EKSTROM trial is to evaluate the effects of colchicine 0.5mg/day on atherosclerotic plaque.

Methods

Eighty-four participants will be enrolled after obtaining informed consent and followed for 12 months. Eligible patients will be randomly assigned to colchicine 0.5mg/day or placebo in a 1:1 fashion as add-on to their standard of care. All participants will undergo coronary computed tomography angiography (CCTA) at baseline and at 12 months.

Results

As of November 2023, the study is 100% enrolled with an expected end of study by the second quarter of 2024. The primary endpoint is change in low attenuation plaque volume as measured by CCTA. Secondary endpoints include change in volume of different plaque types (including total atheroma volume, noncalcified plaque volume, dense calcified plaque volume, remodeling index), change in inflammatory markers (IL-6, IL-1β, IL-18, hs-CRP), change in pericoronary adipose tissue attenuation, change in epicardial adipose tissue volume and attenuation and change in brachial flow mediated dilation.

Conclusion

EKSTROM is the first randomized study to assess the effects of colchicine on plaque progression, pericoronary and epicardial fat. EKSTROM will provide important information on the mechanistic effects of colchicine on the cardiovascular system.

Trial registration

Registry: clinicaltrials.gov, Registration Number: NCT06342609 url: https://www.clinicaltrials.gov/study/NCT06342609?term=EKSTROM&rank=1

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来源期刊
American heart journal
American heart journal 医学-心血管系统
CiteScore
8.20
自引率
2.10%
发文量
214
审稿时长
38 days
期刊介绍: The American Heart Journal will consider for publication suitable articles on topics pertaining to the broad discipline of cardiovascular disease. Our goal is to provide the reader primary investigation, scholarly review, and opinion concerning the practice of cardiovascular medicine. We especially encourage submission of 3 types of reports that are not frequently seen in cardiovascular journals: negative clinical studies, reports on study designs, and studies involving the organization of medical care. The Journal does not accept individual case reports or original articles involving bench laboratory or animal research.
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