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Clinical Trials in South Korea / NCT04499859
Recruiting Phase 4

Low Dose Rosuvastatin Plus Ezetimibe Versus High-dose Rosuvastatin in AMI

NCT04499859 · tracked via the Priya Life Science South Korea tracker
Sponsor
Kiyuk Chang, MD,PhD
Phase
Phase 4
Started
2020-10-01
Last updated
2025-07-30

Condition(s) studied

Myocardial InfarctionStatin Adverse ReactionHMG-CoA Reductase Inhibitor Toxicity

Investigational drug(s) / intervention(s)

Ezetimibe 10mg + Rosuvastatin 5mgAll Ezetimibe trials (15) →All Rosuvastatin trials (36) →Rosuvastatin 20mg →

Ezetimibe 10mg + Rosuvastatin 5mg: Initial use of 10mg of ezetimibe combined with 5 mg of rosuvastatin

Rosuvastatin 20mg: 20mg of Rosuvastatin as a standard treatment for AMI patients

Study 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.

Eligibility

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
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)

Primary outcome measure(s)

  • Major Adverse Cardiovascular Events (MACE) — 24 months
    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.

Trial sites (7)

FacilityCityRegionStatus
Bucheon St.Mary Hospital Bucheon-si Gyeonggido Recruiting
St.Vincent's Hospital Suwon Gyeonggido Recruiting
Uijeongbu St.Mary's Hospital Uijeongbu-si Gyeonggido 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

Other trials for the same condition

Potassium-Competitive Acid Blocker Versus pROton-Pump Inhibitor for GastroproTECTion Strategies In Patients at High Gastro-Intestinal Bleeding Risk Receiving Antithrombotic Therapy Recruiting
OCT Versus Angiography for Culprit Lesion Revascularization in Acute Myocardial Infarction PatiEnts Recruiting
Coronary Microvascular Dysfunction Assessments in Myocardial Infarction With Non-Obstructive Coronary Arteries Recruiting
KOMATE Registry: Korean Multicenter Angioplasty Team Recruiting
SGLT2 Inhibitors on Clinical Outcomes and Left Ventricular Remodeling in Type 2 Diabetic Patients with Acute Myocardial Infarction, a Prospective, Multi-center Registry Study Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04499859 on ClinicalTrials.gov ↗ ← All trials in South Korea