{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,23]],"date-time":"2026-09-23T06:17:52Z","timestamp":1790144272967,"version":"4.0.1"},"reference-count":27,"publisher":"BMJ","issue":"11","license":[{"start":{"date-parts":[[2025,11,5]],"date-time":"2025-11-05T00:00:00Z","timestamp":1762300800000},"content-version":"unspecified","delay-in-days":4,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Hanmi Pharmaceutical"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2025,8,7]]},"published-print":{"date-parts":[[2025,11]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>High-intensity statin therapy is recommended as a first-line strategy for lowering low-density lipoprotein cholesterol (LDL-C) levels in patients with acute myocardial infarction (AMI). A combination of moderate-intensity statin and ezetimibe at an equivalent dose to high-intensity statin may achieve similar LDL-C reduction with fewer side effects. This study evaluates the long-term efficacy and safety of this approach, initiated following AMI, compared with high-intensity statin monotherapy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>The ROSUZET-AMI trial is a multicentre, prospective, open-label, randomised, non-inferiority trial. Patients with AMI who underwent percutaneous coronary intervention were randomised 1:1 to receive either moderate-intensity statin with ezetimibe (rosuvastatin 5\u2009mg with ezetimibe 10\u2009mg) or high-intensity statin monotherapy (rosuvastatin 20\u2009mg). The primary endpoint is the composite of cardiovascular death, major coronary events (non-fatal myocardial infarction, documented unstable angina requiring hospitalisation and all coronary revascularisation events occurring at least 30 days after randomisation), or non-fatal stroke.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>Ethics approval for this study was obtained from the Institutional Review Board of Seoul St. Mary\u2019s Hospital (No. 2020-0424-0003). Informed consent is obtained from every participant before randomisation. The results of this study will be submitted for publication in international peer-reviewed journals, and the key findings will be presented at international scientific conferences.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT04499859\">NCT04499859<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2025-104127","type":"journal-article","created":{"date-parts":[[2025,11,6]],"date-time":"2025-11-06T06:20:34Z","timestamp":1762410034000},"page":"e104127","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":1,"title":["High-Intensity Statin versus Upfront Equivalent-Dose Combination of Moderate-Intensity Statin with Ezetimibe Following Acute Myocardial Infarction (ROSUZET-AMI): protocol of a multicentre, open-label, randomised non-inferiority trial"],"prefix":"10.1136","volume":"15","clinical-trial-number":[{"clinical-trial-number":"nct04499859","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3166-3176","authenticated-orcid":false,"given":"Eun Ho","family":"Choo","sequence":"first","affiliation":[{"name":"Seoul St.Mary's Hospital, The Catholic University of Korea, Seoul, Korea (the Republic of)"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chan Joon","family":"Kim","sequence":"additional","affiliation":[{"name":"Uijeongbu St.Mary's Hospital, The Catholic University of Korea, Uijeongbu, Korea (the Republic of)"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Byung-Hee","family":"Hwang","sequence":"additional","affiliation":[{"name":"Seoul St.Mary's Hospital, The Catholic University of Korea, Seoul, Korea (the Republic of)"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kwan Yong","family":"Lee","sequence":"additional","affiliation":[{"name":"Seoul St.Mary's Hospital, The Catholic University of Korea, Seoul, Korea (the Republic of)"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gyu Chul","family":"Oh","sequence":"additional","affiliation":[{"name":"Seoul St.Mary's Hospital, The Catholic University of Korea, Seoul, Korea (the Republic of)"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sungmin","family":"Lim","sequence":"additional","affiliation":[{"name":"Uijeongbu St.Mary's Hospital, The Catholic University of Korea, Uijeongbu, Korea (the Republic of)"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9996-2346","authenticated-orcid":false,"given":"Ik Jun","family":"Choi","sequence":"additional","affiliation":[{"name":"Incheon St. Mary\u2019s Hospital, The Catholic University of Korea, Incheon, Korea (the Republic of)"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0219-190X","authenticated-orcid":false,"given":"Dong-Bin","family":"Kim","sequence":"additional","affiliation":[{"name":"Bucheon St. Mary\u2019s Hospital, The Catholic University of Korea, Bucheon, Korea (the Republic of)"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"O Sung","family":"Kwon","sequence":"additional","affiliation":[{"name":"Eunpyeong St.Mary's Hospital, The Catholic University of Korea, Seoul, Korea (the Republic of)"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sunam","family":"Lee","sequence":"additional","affiliation":[{"name":"St. Vincent Hospital, The Catholic University of Korea, Suwon, Korea (the Republic of)"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yunseok","family":"Choi","sequence":"additional","affiliation":[{"name":"Seoul St.Mary's Hospital, The Catholic University of Korea, Seoul, Korea (the Republic of)"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chul-Soo","family":"Park","sequence":"additional","affiliation":[{"name":"Yeouido St. Mary\u2019s Hospital, The Catholic University of Korea, Seoul, Korea (the Republic of)"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mahn-Won","family":"Park","sequence":"additional","affiliation":[{"name":"Daejeon St.Mary's Hospital, The Catholic University of Korea, Daejeon, Korea (the Republic of)"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hee-Yeol","family":"Kim","sequence":"additional","affiliation":[{"name":"Bucheon St. Mary\u2019s Hospital, The Catholic University of Korea, Bucheon, Korea (the Republic of)"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Han Cheol","family":"Lee","sequence":"additional","affiliation":[{"name":"Pusan National University Hospital, Busan, Korea (the Republic of)"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tae Soo","family":"Kang","sequence":"additional","affiliation":[{"name":"Dankook University Hospital, Cheonan-si, Korea (the Republic of)"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joong Kyung","family":"Sung","sequence":"additional","affiliation":[{"name":"Andong Medical Group Hospital, Andong, Korea (the Republic of)"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Seong-Ill","family":"Woo","sequence":"additional","affiliation":[{"name":"Inha University Hospital, Incheon, Korea (the Republic of)"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hun Sik","family":"Park","sequence":"additional","affiliation":[{"name":"Kyungpook National University Hospital, Daegu, Korea (the Republic of)"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kyeong Ho","family":"Yun","sequence":"additional","affiliation":[{"name":"Wonkwang University Hospital, Iksan-si, Korea (the Republic of)"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kiyuk","family":"Chang","sequence":"additional","affiliation":[{"name":"Seoul St.Mary's Hospital, The Catholic University of Korea, Seoul, Korea (the Republic of)"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2025,11,5]]},"reference":[{"key":"2025120413261647000_15.11.e104127.1","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehz455"},{"key":"2025120413261647000_15.11.e104127.2","doi-asserted-by":"publisher","DOI":"10.1161\/CIR.0000000000000624"},{"key":"2025120413261647000_15.11.e104127.3","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehy182"},{"key":"2025120413261647000_15.11.e104127.4","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2016.02.071"},{"key":"2025120413261647000_15.11.e104127.5","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1410489"},{"key":"2025120413261647000_15.11.e104127.6","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehx162"},{"key":"2025120413261647000_15.11.e104127.7","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(22)00916-3"},{"key":"2025120413261647000_15.11.e104127.8","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2006.10.064"},{"key":"2025120413261647000_15.11.e104127.9","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2010.02.026"},{"key":"2025120413261647000_15.11.e104127.10","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2015.05.065"},{"key":"2025120413261647000_15.11.e104127.11","doi-asserted-by":"publisher","DOI":"10.1161\/CIR.0000000000000617"},{"key":"2025120413261647000_15.11.e104127.12","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2017.07.752"},{"key":"2025120413261647000_15.11.e104127.13","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa040583"},{"key":"2025120413261647000_15.11.e104127.14","doi-asserted-by":"crossref","first-page":"384","DOI":"10.1016\/j.amjmed.2015.10.024","article-title":"2013 Cholesterol Guidelines Revisited: Percent LDL Cholesterol Reduction or Attained LDL Cholesterol Level or Both for Prognosis?","volume":"129","author":"Bangalore","year":"2016","journal-title":"Am J Med"},{"key":"2025120413261647000_15.11.e104127.15","doi-asserted-by":"crossref","first-page":"158","DOI":"10.1016\/j.atherosclerosis.2017.08.013","article-title":"Cholesterol target value attainment and lipid-lowering therapy in patients with stable or acute coronary heart disease: Results from the Dyslipidemia International Study II","volume":"266","author":"Gitt","year":"2017","journal-title":"Atherosclerosis"},{"key":"2025120413261647000_15.11.e104127.16","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehw046"},{"key":"2025120413261647000_15.11.e104127.17","doi-asserted-by":"publisher","DOI":"10.1016\/j.clinthera.2004.11.016"},{"key":"2025120413261647000_15.11.e104127.18","doi-asserted-by":"publisher","DOI":"10.1161\/01.CIR.0000034044.95911.DC"},{"key":"2025120413261647000_15.11.e104127.19","doi-asserted-by":"publisher","DOI":"10.1016\/j.amjcard.2013.08.031"},{"key":"2025120413261647000_15.11.e104127.20","doi-asserted-by":"crossref","first-page":"22","DOI":"10.1016\/j.amjcard.2021.05.039","article-title":"Effect of Atorvastatin (10 mg) and Ezetimibe (10 mg) Combination Compared to Atorvastatin (40 mg) Alone on Coronary Atherosclerosis","volume":"154","author":"Oh","year":"2021","journal-title":"Am J Cardiol"},{"key":"2025120413261647000_15.11.e104127.21","doi-asserted-by":"publisher","DOI":"10.1111\/1755-5922.12213"},{"key":"2025120413261647000_15.11.e104127.22","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehz458"},{"key":"2025120413261647000_15.11.e104127.23","doi-asserted-by":"crossref","first-page":"49","DOI":"10.1016\/j.ijcard.2017.02.099","article-title":"A randomized, controlled comparison of different intensive lipid-lowering therapies in Chinese patients with non-ST-elevation acute coronary syndrome (NSTE-ACS): Ezetimibe and rosuvastatin versus high-dose rosuvastatin","volume":"235","author":"Ran","year":"2017","journal-title":"Int J Cardiol"},{"key":"2025120413261647000_15.11.e104127.24","doi-asserted-by":"crossref","first-page":"126","DOI":"10.1016\/j.ijcard.2015.07.016","article-title":"Vascular and metabolic effects of ezetimibe combined with simvastatin in patients with hypercholesterolemia","volume":"199","author":"Koh","year":"2015","journal-title":"Int J Cardiol"},{"key":"2025120413261647000_15.11.e104127.25","doi-asserted-by":"crossref","first-page":"547","DOI":"10.1001\/jamacardio.2017.0083","article-title":"Long-term Safety and Efficacy of Achieving Very Low Levels of Low-Density Lipoprotein Cholesterol: A Prespecified Analysis of the IMPROVE-IT Trial","volume":"2","author":"Giugliano","year":"2017","journal-title":"JAMA Cardiol"},{"key":"2025120413261647000_15.11.e104127.26","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2016.14568"},{"key":"2025120413261647000_15.11.e104127.27","doi-asserted-by":"crossref","DOI":"10.1186\/s12933-024-02498-3","article-title":"Efficacy and diabetes risk of moderate-intensity statin plus ezetimibe versus high-intensity statin after percutaneous coronary intervention","volume":"23","author":"Choo","year":"2024","journal-title":"Cardiovasc Diabetol"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2025-104127","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,4]],"date-time":"2025-12-04T21:27:25Z","timestamp":1764883645000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2025-104127"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,11]]},"references-count":27,"journal-issue":{"issue":"11","published-online":{"date-parts":[[2025,11,5]]},"published-print":{"date-parts":[[2025,11]]}},"alternative-id":["10.1136\/bmjopen-2025-104127"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2025-104127","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,11]]}}}