Comparing low dose rosuvastatin with ezetimibe to high dose rosuvastatin in heart attack patients
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
PHASE4 · The Catholic University of Korea · NCT04499859
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 | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 3548 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | The Catholic University of Korea (other) |
| Locations | 7 sites (Bucheon-si, Gyeonggido and 6 other locations) |
| Trial ID | NCT04499859 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 19 and older who have been diagnosed with myocardial infarction and treated with percutaneous coronary intervention.
Not a fit: Patients with life-threatening conditions, chronic liver disease, or those who are pregnant or breastfeeding may not benefit from this study.
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 performed: Previous studies have shown promising results with similar combination therapies, but this specific approach is still being evaluated for its efficacy.
Eligibility criteria
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 this trial is running
Bucheon-si, Gyeonggido and 6 other locations
- 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)
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Myocardial Infarction, Statin Adverse Reaction, HMG-CoA Reductase Inhibitor Toxicity