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

NCT ID: NCT04499859

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 3548 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2027-08-30

Brief 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.

Detailed Description

IMPROVE-IT (Improved Reduction of Outcomes: Vytorin Efficacy International Trial) study showed that even when statin is not used as a treatment the rate of decrease of LDL cholesterol is correlated to the risk of heart disease. Yet whether concomitant use of ezetimibe and statin will have similar degree of clinical efficacy as single use of high dose statin in decreasing LDL cholesterol level needs further examination.

Conditions

Myocardial Infarction; Statin Adverse Reaction; HMG-CoA Reductase Inhibitor Toxicity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ezetimibe 10 mg plus rosuvastatin 5 mg

Rosuzet 5/10 mg , once a day for 24 months

Group Type: EXPERIMENTAL

Ezetimibe 10mg + Rosuvastatin 5mg

Intervention Type: DRUG

Initial use of 10mg of ezetimibe combined with 5 mg of rosuvastatin

rosuvastatin 20 mg only

Any brand drugs of rosuvastatin 20mg, once a day for 24 months

Group Type: ACTIVE_COMPARATOR

Rosuvastatin 20mg

Intervention Type: DRUG

20mg of Rosuvastatin as a standard treatment for AMI patients

Interventions

Ezetimibe 10mg + Rosuvastatin 5mg

Initial use of 10mg of ezetimibe combined with 5 mg of rosuvastatin

Intervention Type: DRUG

Rosuvastatin 20mg

20mg of Rosuvastatin as a standard treatment for AMI patients

Intervention Type: DRUG

Other Intervention Names

Rosuzet 10/5 mg; Crestor 20mg

Eligibility 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)

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kiyuk Chang, MD,PhD

OTHER

Sponsor Role: lead

Responsible Party

Kiyuk Chang, MD,PhD

Professor of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kiyuk Chang, MD,PhD

Role: STUDY_CHAIR

Seoul St. Mary's Hospital

Locations

Bucheon St.Mary Hospital

Bucheon-si, Gyeonggido, South Korea

Site Status: RECRUITING

St.Vincent's Hospital

Suwon, Gyeonggido, South Korea

Site Status: RECRUITING

Uijeongbu St.Mary's Hospital

Uijeongbu-si, Gyeonggido, South Korea

Site Status: RECRUITING

Daejeon St.Mary's Hospital

Daejeon, , South Korea

Site Status: RECRUITING

Incheon St.Mary's Hospital

Incheon, , South Korea

Site Status: RECRUITING

Seoul St.Mary's Hospital

Seoul, , South Korea

Site Status: RECRUITING

Yeouido St.Mary Hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Kiyuk Chang, MD,PhD

Role: CONTACT

kiyuk@catholic.ac.kr

82-10-9175-2076

Eun Ho Choo, MD

Role: CONTACT

cmcchu@catholic.ac.kr

82-10-8500-4569

Facility Contacts

Hee Yeol Kim, M.D.

Role: primary

Ki-Dong Yoo, M.D.

Role: primary

Chan Joon Kim, M.D.

Role: primary

Man Won Park, M.D.

Role: primary

Doo Soo Jeon, M.D.

Role: primary

Chul-Soo Park, M.D.

Role: primary

Other Identifiers

ROSUZET-AMI

Identifier Type: -

Identifier Source: org_study_id