Overview

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

Status:
Not yet recruiting

Trial end date:
2024-07-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Kiyuk Chang, MD,PhD

Treatments:

Rosuvastatin Calcium

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)