Low Dose Rosuvastatin Plus Ezetimibe Versus High-dose Rosuvastatin in AMI
ROSUZET-AMI
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
1 other identifier
interventional
3,548
1 country
7
Brief Summary
Combination therapy of rosuvastatin 5mg and ezetimibe 10 mg showed similar achievement rate in decreasing LDL cholesterol level by 50% as single use of rosuvastatin 20 mg. This trial aims to prove non-inferiority of concomitant usage of low dose rosuvastatin and ezetimibe among patients with acute myocardial infarction who went through percutaneous coronary intervention at decreasing major adverse cardiac events compared to the efficacy of single use of high dose rosuvastatin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2020
Longer than P75 for phase_4
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 29, 2020
CompletedFirst Posted
Study publicly available on registry
August 5, 2020
CompletedStudy Start
First participant enrolled
October 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 30, 2027
July 30, 2025
July 1, 2025
5.9 years
July 29, 2020
July 28, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Major Adverse Cardiovascular Events (MACE)
A composite of cardiovascular death, major coronary events (non-fatal MI, documented unstable angina requiring hospital admission, all coronary revascularization with either PCI or bypass surgery occurring at least 30 days after randomization), or non-fatal stroke.
24 months
Secondary Outcomes (14)
death from any cause, a major coronary event, or a non-fatal stroke
24 months
cardiovascular death, non-fatal MI, or non-fatal stroke
24 months
all-cause death from any cause
24months
cardiovascular death
24months
any myocardial infaction
24 months
- +9 more secondary outcomes
Study Arms (2)
ezetimibe 10 mg plus rosuvastatin 5 mg
EXPERIMENTALRosuzet 5/10 mg , once a day for 24 months
rosuvastatin 20 mg only
ACTIVE COMPARATORAny brand drugs of rosuvastatin 20mg, once a day for 24 months
Interventions
Initial use of 10mg of ezetimibe combined with 5 mg of rosuvastatin
20mg of Rosuvastatin as a standard treatment for AMI patients
Eligibility Criteria
You may qualify if:
- Adults Aged 19 and up
- Patients diagnosed with myocardial infarction (both ST segment elevation and non-ST segment elevation) who were treated with percutaneous coronary intervention (Myocardial infarction defined as in the 4th Universal Definition of Myocardial Infarction)
- For female patients who are of childbearing age, subjects that agreed on taking mandatory pregnancy test
- Patients who agreed and signed on the informed consent form
You may not qualify if:
- Patients with life expectancy of a year or less due to malignancy
- Patients with chronic liver disease
- Patients with sensitivity to active ingredient of the research drugs (ezetimibe and/or rosuvastatin) or patients who are prohibited to take ezetimibe and/or rosuvastatin.
- Pregnant and/or breastfeeding
- Female patients who are unable to use any means of contraception
- Patients receiving hemodialysis, peritoneal dialysis patients and/or kidney transplant patients, due to end stage renal disease
- Patients who participated in other clinical trial(s) within 3 months from the screening (except non-interventional observational study)
- Patients considered inappropriate for the study for any other reason(s) by the inspector(s)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Bucheon St.Mary Hospital
Bucheon-si, Gyeonggido, South Korea
St.Vincent's Hospital
Suwon, Gyeonggido, South Korea
Uijeongbu St.Mary's Hospital
Uijeongbu-si, Gyeonggido, South Korea
Daejeon St.Mary's Hospital
Daejeon, South Korea
Incheon St.Mary's Hospital
Incheon, South Korea
Seoul St.Mary's Hospital
Seoul, 137-701, South Korea
Yeouido St.Mary Hospital
Seoul, South Korea
Related Publications (1)
Choo EH, Kim CJ, Hwang BH, Lee KY, Oh GC, Lim S, Choi IJ, Kim DB, Kwon OS, Lee S, Choi Y, Park CS, Park MW, Kim HY, Lee HC, Kang TS, Sung JK, Woo SI, Park HS, Yun KH, Chang K; ROSUZET-AMI investigator. 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. BMJ Open. 2025 Nov 5;15(11):e104127. doi: 10.1136/bmjopen-2025-104127.
PMID: 41198200DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Kiyuk Chang, MD,PhD
Seoul St. Mary's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
July 29, 2020
First Posted
August 5, 2020
Study Start
October 1, 2020
Primary Completion (Estimated)
August 30, 2026
Study Completion (Estimated)
August 30, 2027
Last Updated
July 30, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share
Aggregate summary data available on reasonable request. Exceptionally, and subject to Steering Committee approval, deidentified core analytic IPD may be accessed in a secure, non-downloadable virtual environment at the coordinating center. Contact PI (Kiyuk Chang) with proposal + ethics documentation; DUA required; costs may apply.