Clinical trial Recruiting at 7 sites Phase 4 Interventional Ages 19 and up

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.

More Myocardial Infarction trials

Quick facts

PhasePhase 4
Study typeInterventional
Ages19 Years and up
SexAll
Enrollment3548 (estimated)
SponsorThe Catholic University of Korea
Academic / other
Locations7 sites (Bucheon-si, Gyeonggido and 6 other locations)
StatusRecruiting
StartedOctober 1, 2020
Main results expectedAugust 30, 2026
Study endsAugust 30, 2027
Registry record updatedJuly 30, 2025
Trial IDNCT04499859 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

  • 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
  • Yeouido St.Mary Hospital
    Seoul, South Korea
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.