Actively Recruiting

Phase 4
Age: 19Years +
All Genders
ID04499859

A Prospective, Randomized Trial Comparing Low-dose Rosuvastatin Plus Ezetimibe Versus High-dose Rosuvastatin in Acute Myocardial Infarction Patients Undergoing Percutaneous Coronary Intervention

Led by Kiyuk Chang, MD,PhD · Updated on 2025-07-30

3548

Participants Needed

7

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate whether using a combination of low dose rosuvastatin (5 mg) and ezetimibe (10 mg) is not less effective than using a higher dose of rosuvastatin (20 mg) alone in reducing major adverse cardiac events for patients with acute myocardial infarction treated with percutaneous coronary intervention. Previous studies have shown the importance of lowering LDL cholesterol in reducing heart disease risk, but the combined treatment's clinical effectiveness needs further study. Participants will be randomly assigned to receive either rosuvastatin 5 mg plus ezetimibe 10 mg once daily or rosuvastatin 20 mg once daily for 24 months. This open-label trial compares the two regimens over two years to assess their impact on heart-related outcomes. The trial is led by Kiyuk Chang, MD, PhD. During the study, participants will be monitored for major adverse cardiovascular events over 24 months, including death, heart attacks, strokes, and need for revascularization. Additional assessments include LDL cholesterol levels at 3 months, medication adherence, muscle symptoms, new diabetes onset, and cataract occurrence. Safety and effectiveness data will be collected regularly to understand the treatments' impact over the two-year period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 19Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 19 and older
  • Patients diagnosed with myocardial infarction (both ST segment elevation and non-ST segment elevation) treated with percutaneous coronary intervention
  • Female patients of childbearing age who agree to mandatory pregnancy testing
  • Patients who have signed informed consent
Not Eligible

You will not qualify if you...

  • Patients with life expectancy of one year or less due to cancer
  • Patients with chronic liver disease
  • Patients sensitive to ezetimibe or rosuvastatin or prohibited from taking these drugs
  • Pregnant or breastfeeding women
  • Female patients unable to use contraception
  • Patients on hemodialysis, peritoneal dialysis, or with kidney transplants due to end-stage renal disease
  • Patients who participated in other clinical trials within 3 months (except non-interventional observational studies)
  • Patients deemed inappropriate for the study by investigators

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 24 months

Participants receive either low-dose rosuvastatin plus ezetimibe or high-dose rosuvastatin daily to manage acute myocardial infarction after percutaneous coronary intervention.

Regular visits throughout 24 months for treatment monitoring

Trial Site Locations

Total: 7 locations

1

Bucheon St.Mary Hospital

Bucheon-si, Gyeonggido, South Korea

Actively Recruiting

2

St.Vincent's Hospital

Suwon, Gyeonggido, South Korea

Actively Recruiting

3

Uijeongbu St.Mary's Hospital

Uijeongbu-si, Gyeonggido, South Korea

Actively Recruiting

4

Daejeon St.Mary's Hospital

Daejeon, South Korea

Actively Recruiting

5

Incheon St.Mary's Hospital

Incheon, South Korea

Actively Recruiting

6

Seoul St.Mary's Hospital

Seoul, South Korea, 137-701

Actively Recruiting

7

Yeouido St.Mary Hospital

Seoul, South Korea

Actively Recruiting

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Research Team

K

Kiyuk Chang, MD,PhD

E

Eun Ho Choo, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Frequently Asked Questions

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Published Research Related To This Trial

High-Intensity Statin versus Upfront Equivalent-Dose Combination of Moderate-Intensity Statin with Ezetimibe Following Acute Myocardial Infarction (ROSUZET-AMI): protocol of a multicentre, open-label, randomised non-inferiority trial.

Eun Ho Choo, Chan Joon Kim, Byung-Hee Hwang...

https://pubmed.ncbi.nlm.nih.gov/41198200