{
  "abstract": "Introduction 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.Methods and analysis 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 mg with ezetimibe 10 mg) or high-intensity statin monotherapy (rosuvastatin 20 mg). 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.Ethics and dissemination Ethics approval for this study was obtained from the Institutional Review Board of Seoul St. Mary’s 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.Trial registration number NCT04499859.",
  "authors": [
    {
      "affiliations": [
        "Seoul St.Mary's Hospital, The Catholic University of Korea, Seoul, Korea (the Republic of)"
      ],
      "name": "Eun Ho Choo"
    },
    {
      "affiliations": [
        "Uijeongbu St.Mary's Hospital, The Catholic University of Korea, Uijeongbu, Korea (the Republic of)"
      ],
      "name": "Chan Joon Kim"
    },
    {
      "affiliations": [
        "Seoul St.Mary's Hospital, The Catholic University of Korea, Seoul, Korea (the Republic of)"
      ],
      "name": "Byung-Hee Hwang"
    },
    {
      "affiliations": [
        "Seoul St.Mary's Hospital, The Catholic University of Korea, Seoul, Korea (the Republic of)"
      ],
      "name": "Kwan Yong Lee"
    },
    {
      "affiliations": [
        "Seoul St.Mary's Hospital, The Catholic University of Korea, Seoul, Korea (the Republic of)"
      ],
      "name": "Gyu Chul Oh"
    },
    {
      "affiliations": [
        "Uijeongbu St.Mary's Hospital, The Catholic University of Korea, Uijeongbu, Korea (the Republic of)"
      ],
      "name": "Sungmin Lim"
    },
    {
      "affiliations": [
        "Incheon St. Mary’s Hospital, The Catholic University of Korea, Incheon, Korea (the Republic of)"
      ],
      "name": "Ik Jun Choi"
    },
    {
      "affiliations": [
        "Bucheon St. Mary’s Hospital, The Catholic University of Korea, Bucheon, Korea (the Republic of)"
      ],
      "name": "Dong-Bin Kim"
    },
    {
      "affiliations": [
        "Eunpyeong St.Mary's Hospital, The Catholic University of Korea, Seoul, Korea (the Republic of)"
      ],
      "name": "O Sung Kwon"
    },
    {
      "affiliations": [
        "St. Vincent Hospital, The Catholic University of Korea, Suwon, Korea (the Republic of)"
      ],
      "name": "Sunam Lee"
    },
    {
      "affiliations": [
        "Seoul St.Mary's Hospital, The Catholic University of Korea, Seoul, Korea (the Republic of)"
      ],
      "name": "Yunseok Choi"
    },
    {
      "affiliations": [
        "Yeouido St. Mary’s Hospital, The Catholic University of Korea, Seoul, Korea (the Republic of)"
      ],
      "name": "Chul-Soo Park"
    },
    {
      "affiliations": [
        "Daejeon St.Mary's Hospital, The Catholic University of Korea, Daejeon, Korea (the Republic of)"
      ],
      "name": "Mahn-Won Park"
    },
    {
      "affiliations": [
        "Bucheon St. Mary’s Hospital, The Catholic University of Korea, Bucheon, Korea (the Republic of)"
      ],
      "name": "Hee-Yeol Kim"
    },
    {
      "affiliations": [
        "Pusan National University Hospital, Busan, Korea (the Republic of)"
      ],
      "name": "Han Cheol Lee"
    },
    {
      "affiliations": [
        "Dankook University Hospital, Cheonan-si, Korea (the Republic of)"
      ],
      "name": "Tae Soo Kang"
    },
    {
      "affiliations": [
        "Andong Medical Group Hospital, Andong, Korea (the Republic of)"
      ],
      "name": "Joong Kyung Sung"
    },
    {
      "affiliations": [
        "Inha University Hospital, Incheon, Korea (the Republic of)"
      ],
      "name": "Seong-Ill Woo"
    },
    {
      "affiliations": [
        "Kyungpook National University Hospital, Daegu, Korea (the Republic of)"
      ],
      "name": "Hun Sik Park"
    },
    {
      "affiliations": [
        "Wonkwang University Hospital, Iksan-si, Korea (the Republic of)"
      ],
      "name": "Kyeong Ho Yun"
    },
    {
      "affiliations": [
        "Seoul St.Mary's Hospital, The Catholic University of Korea, Seoul, Korea (the Republic of)"
      ],
      "name": "Kiyuk Chang"
    },
    {
      "affiliations": [],
      "name": "On behalf of the ROSUZET-AMI investigator"
    }
  ],
  "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",
  "uid": "b9760ef1-c009-5df2-a36c-6ab01ada9940"
}