NCT04499859RecruitingPhase 4
Low Dose Rosuvastatin Plus Ezetimibe Versus High-dose Rosuvastatin in 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
Source: ClinicalTrials.gov · Last updated 30 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 3548 (estimated)
- First submitted
- 29 Jul 2020
- Start date
- 1 Oct 2020
- Primary completion date
- 30 Aug 2026
- Lead sponsor
- Kiyuk Chang, MD,PhD
- Diseases
- Coronary artery disease
- NCT number
- NCT04499859
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 3548
- From 1 Oct 2020 to the primary completion date, 30 Aug 2026
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Patients receiving hemodialysis, peritoneal dialysis patients and/or kidney transplant patients, due to end stage renal disease
Other illness
- Patients with life expectancy of a year or less due to malignancy
- Patients with chronic liver disease
Other
- Pregnant and/or breastfeeding
- Female patients who are unable to use any means of contraception
- 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)
Who the study is looking for
- 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
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Bucheon St.Mary Hospital Coordinator of this site? Confirm its status | Bucheon-si | South Korea | Recruiting |
| Daejeon St.Mary's Hospital Coordinator of this site? Confirm its status | Daejeon | South Korea | Recruiting |
| Incheon St.Mary's Hospital Coordinator of this site? Confirm its status | Incheon | South Korea | Recruiting |
| Yeouido St.Mary Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Seoul St. Mary's Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| St. Vincent's Hospital Coordinator of this site? Confirm its status | Suwon | South Korea | Recruiting |
| Uijeongbu ST. Mary's Hospital Coordinator of this site? Confirm its status | Uijeongbu-si | South Korea | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.