Dhiran Verghese MD , Sajad Hamal MS , Ahmed Ghanem MD , April Kinninger MPH , Denise Javier MD , Keshi Ichikawa MD , Travis Benzing MD , Srikanth Krishnan MD , Sina Kianoush MD , Hossein Hamidi MD , Marziyeh Bagheri MD , Divya Abraham MD , Mina Deljavanghodrati MD , Ayesha Ghoto MD , Jairo Aldana-Bitar MD , Matthew Budoff MD
{"title":"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。","authors":"Dhiran Verghese MD , Sajad Hamal MS , Ahmed Ghanem MD , April Kinninger MPH , Denise Javier MD , Keshi Ichikawa MD , Travis Benzing MD , Srikanth Krishnan MD , Sina Kianoush MD , Hossein Hamidi MD , Marziyeh Bagheri MD , Divya Abraham MD , Mina Deljavanghodrati MD , Ayesha Ghoto MD , Jairo Aldana-Bitar MD , Matthew Budoff MD","doi":"10.1016/j.ahj.2024.07.005","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><p>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.</p></div><div><h3>Methods</h3><p>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.</p></div><div><h3>Results</h3><p>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.</p></div><div><h3>Conclusion</h3><p>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.</p></div><div><h3>Trial registration</h3><p>Registry: clinicaltrials.gov, Registration Number: NCT06342609 url: https://www.clinicaltrials.gov/study/NCT06342609?term=EKSTROM&rank=1</p></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"277 ","pages":"Pages 20-26"},"PeriodicalIF":3.7000,"publicationDate":"2024-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Effect of colchicine on progression of known coronary atherosclerosis in patients with STable CoROnary artery disease CoMpared to placebo (EKSTROM) trial—rationale and design\",\"authors\":\"Dhiran Verghese MD , Sajad Hamal MS , Ahmed Ghanem MD , April Kinninger MPH , Denise Javier MD , Keshi Ichikawa MD , Travis Benzing MD , Srikanth Krishnan MD , Sina Kianoush MD , Hossein Hamidi MD , Marziyeh Bagheri MD , Divya Abraham MD , Mina Deljavanghodrati MD , Ayesha Ghoto MD , Jairo Aldana-Bitar MD , Matthew Budoff MD\",\"doi\":\"10.1016/j.ahj.2024.07.005\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><p>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.</p></div><div><h3>Methods</h3><p>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.</p></div><div><h3>Results</h3><p>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.</p></div><div><h3>Conclusion</h3><p>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.</p></div><div><h3>Trial registration</h3><p>Registry: clinicaltrials.gov, Registration Number: NCT06342609 url: https://www.clinicaltrials.gov/study/NCT06342609?term=EKSTROM&rank=1</p></div>\",\"PeriodicalId\":7868,\"journal\":{\"name\":\"American heart journal\",\"volume\":\"277 \",\"pages\":\"Pages 20-26\"},\"PeriodicalIF\":3.7000,\"publicationDate\":\"2024-07-17\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"American heart journal\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S0002870324001716\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"CARDIAC & CARDIOVASCULAR SYSTEMS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"American heart journal","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0002870324001716","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
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.
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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