Comparing low dose rosuvastatin with ezetimibe to high dose rosuvastatin in heart attack patients
Official title: 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
Run by The Catholic University of Korea · NCT04499859 · Data updated 2026-11-12
This study is testing if a lower dose of rosuvastatin combined with ezetimibe can lower cholesterol and reduce heart problems just as well as a higher dose of rosuvastatin in heart attack patients.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 3548 (estimated) |
| Sponsor | The Catholic University of Korea Academic / other |
| Locations | 7 sites (Bucheon-si, Gyeonggido and 6 other locations) |
| Status | Recruiting |
| Started | October 1, 2020 |
| Main results expected | August 30, 2026 |
| Study ends | August 30, 2027 |
| Registry record updated | July 30, 2025 |
| Trial ID | NCT04499859 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 19 and older who have been diagnosed with myocardial infarction and treated with percutaneous coronary intervention.
✕Probably not a fit
Patients with life-threatening conditions, chronic liver disease, or those who are pregnant or breastfeeding may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effectiveness of a combination therapy using low dose rosuvastatin (5mg) and ezetimibe (10mg) compared to high dose rosuvastatin (20mg) in patients who have experienced an acute myocardial infarction and undergone percutaneous coronary intervention. The goal is to determine if the combination therapy can achieve similar reductions in LDL cholesterol levels and decrease major adverse cardiac events. The study builds on previous findings that link LDL cholesterol reduction to heart disease risk, aiming to provide a potentially safer alternative to high-dose statin therapy.
Why it matters
Potential benefit: If successful, this study could offer a safer and equally effective treatment option for patients recovering from a heart attack.
How similar studies have gone: Previous studies have shown promising results with similar combination therapies, but this specific approach is still being evaluated for its efficacy.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adults Aged 19 and up 2. 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) 3. For female patients who are of childbearing age, subjects that agreed on taking mandatory pregnancy test 4. Patients who agreed and signed on the informed consent form Exclusion Criteria: 1. Patients with life expectancy of a year or less due to malignancy 2. Patients with chronic liver disease 3. 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. 4. Pregnant and/or breastfeeding 5. Female patients who are unable to use any means of contraception 6. Patients receiving hemodialysis, peritoneal dialysis patients and/or kidney transplant patients, due to end stage renal disease 7. Patients who participated in other clinical trial(s) within 3 months from the screening (except non-interventional observational study) 8. Patients considered inappropriate for the study for any other reason(s) by the inspector(s)
Where it's running
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Bucheon St.Mary Hospital
Bucheon-si, Gyeonggido, South Korea Recruiting -
St.Vincent's Hospital
Suwon, Gyeonggido, South Korea Recruiting -
Uijeongbu St.Mary's Hospital
Uijeongbu-si, Gyeonggido, South Korea Recruiting -
Daejeon St.Mary's Hospital
Daejeon, South Korea Recruiting -
Incheon St.Mary's Hospital
Incheon, South Korea Recruiting -
Seoul St.Mary's Hospital
Seoul, South Korea Recruiting
Show 1 more location
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Yeouido St.Mary Hospital
Seoul, South Korea Recruiting
Study contacts
- Study coordinator: Kiyuk Chang, MD,PhD
- Email: kiyuk@catholic.ac.kr
- Phone: 82-10-9175-2076
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.