Evidence mapPaperPMID 41198200Full record

ArticleBMJ open2025

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.

Eun Ho Choo, Chan Joon Kim, Byung-Hee Hwang, Kwan Yong Lee, Gyu Chul Oh, Sungmin Lim, Ik Jun Choi, Dong-Bin Kim, O Sung Kwon, Sunam Lee and 12 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT04499859. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04499859 phase4recruiting

A Prospective, Multicenter, Randomized, Open-label Trial to Compare Low-dose ROSUvastatin Plus eZETimibe Versus High-dose Rosuvastatin in Patients With Acute Myocardial Infarction Undergoing Percutaneous Coronary Intervention

Ran2020Enrolled3,548Registered outcomes15Posted comparisons0ConditionsHMG-CoA Reductase Inhibitor Toxicity, Myocardial Infarction, Statin Adverse ReactionArmsEzetimibe 10mg + Rosuvastatin 5mg, Rosuvastatin 20mg
Open the trial in the graph
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

22 authors.

Eun Ho ChooSeoul St.Mary's Hospital, The Catholic University of Korea, Seoul, Korea (the Republic of).ORCID http://orcid.org/0000-0003-3166-3176
Chan Joon KimUijeongbu St.Mary's Hospital, The Catholic University of Korea, Uijeongbu, Korea (the Republic of).
Byung-Hee HwangSeoul St.Mary's Hospital, The Catholic University of Korea, Seoul, Korea (the Republic of).
Kwan Yong LeeSeoul St.Mary's Hospital, The Catholic University of Korea, Seoul, Korea (the Republic of).
Gyu Chul OhSeoul St.Mary's Hospital, The Catholic University of Korea, Seoul, Korea (the Republic of).
Sungmin LimUijeongbu St.Mary's Hospital, The Catholic University of Korea, Uijeongbu, Korea (the Republic of).
Ik Jun ChoiIncheon St. Mary's Hospital, The Catholic University of Korea, Incheon, Korea (the Republic of).ORCID http://orcid.org/0000-0001-9996-2346
Dong-Bin KimBucheon St. Mary's Hospital, The Catholic University of Korea, Bucheon, Korea (the Republic of).ORCID http://orcid.org/0000-0002-0219-190X
O Sung KwonEunpyeong St.Mary's Hospital, The Catholic University of Korea, Seoul, Korea (the Republic of).
Sunam LeeSt. Vincent Hospital, The Catholic University of Korea, Suwon, Korea (the Republic of).
Yunseok ChoiSeoul St.Mary's Hospital, The Catholic University of Korea, Seoul, Korea (the Republic of).
Chul-Soo ParkYeouido St. Mary's Hospital, The Catholic University of Korea, Seoul, Korea (the Republic of).
Mahn-Won ParkDaejeon St.Mary's Hospital, The Catholic University of Korea, Daejeon, Korea (the Republic of).
Hee-Yeol KimBucheon St. Mary's Hospital, The Catholic University of Korea, Bucheon, Korea (the Republic of).
Han Cheol LeePusan National University Hospital, Busan, Korea (the Republic of).
Tae Soo KangDankook University Hospital, Cheonan-si, Korea (the Republic of).
Joong Kyung SungAndong Medical Group Hospital, Andong, Korea (the Republic of).
Seong-Ill WooInha University Hospital, Incheon, Korea (the Republic of).
Hun Sik ParkKyungpook National University Hospital, Daegu, Korea (the Republic of).
Kyeong Ho YunWonkwang University Hospital, Iksan-si, Korea (the Republic of).
Kiyuk ChangSeoul St.Mary's Hospital, The Catholic University of Korea, Seoul, Korea (the Republic of) kiyuk@catholic.ac.kr.
ROSUZET-AMI investigator

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionHigh-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.

Indexed as

Anticholesteremic AgentsEzetimibeHydroxymethylglutaryl-CoA Reductase InhibitorsMyocardial InfarctionRosuvastatin CalciumAgedCholesterol, LDLDrug Therapy, CombinationEquivalence Trials as TopicFemaleHumansMaleMiddle AgedMulticenter Studies as TopicPercutaneous Coronary InterventionProspective StudiesAnticholesteremic AgentsCholesterol, LDLEzetimibeHydroxymethylglutaryl-CoA Reductase InhibitorsRosuvastatin CalciumIschaemic heart diseaseLipid disordersMyocardial infarction

Identifiers

PMID41198200
PMCPMC12593476

What Socratic holds

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LicenceCC BY-NC
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.