RecruitingPhase 4NCT04499859

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

Sponsor

Kiyuk Chang, MD,PhD

Enrollment

3,548 participants

Start Date

Oct 1, 2020

Study Type

INTERVENTIONAL

Conditions

Myocardial Infarction Statin Adverse Reaction HMG-CoA Reductase Inhibitor Toxicity

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

Min Age: 19 Years

Inclusion Criteria4

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

Exclusion Criteria8

Patients with life expectancy of a year or less due to malignancy
Patients with chronic liver disease
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.
Pregnant and/or breastfeeding
Female patients who are unable to use any means of contraception
Patients receiving hemodialysis, peritoneal dialysis patients and/or kidney transplant patients, due to end stage renal disease
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)

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