Low Dose Rosuvastatin Plus Ezetimibe Versus High-dose Rosuvastatin in AMI (ROSUZET-AMI)

July 28, 2025 updated by: Kiyuk Chang, MD,PhD

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3548

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Daejeon, Korea, Republic of
        • Recruiting
        • Daejeon St.Mary's Hospital
        • Contact:
          • Man Won Park, M.D.
      • Incheon, Korea, Republic of
        • Recruiting
        • Incheon St.Mary's Hospital
        • Contact:
          • Doo Soo Jeon, M.D.
      • Seoul, Korea, Republic of, 137-701
        • Recruiting
        • Seoul St.Mary's Hospital
        • Principal Investigator:
          • Kiyuk Chang, M.D.
      • Seoul, Korea, Republic of
        • Recruiting
        • Yeouido St.Mary Hospital
        • Contact:
          • Chul-Soo Park, M.D.
    • Gyeonggido
      • Bucheon, Gyeonggido, Korea, Republic of
        • Recruiting
        • Bucheon St.Mary Hospital
        • Contact:
          • Hee Yeol Kim, M.D.
      • Suwon, Gyeonggido, Korea, Republic of
        • Recruiting
        • St.Vincent's Hospital
        • Contact:
          • Ki-Dong Yoo, M.D.
      • Uijeongbu, Gyeonggido, Korea, Republic of
        • Recruiting
        • Uijeongbu St.Mary's Hospital
        • Contact:
          • Chan Joon Kim, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ezetimibe 10 mg plus rosuvastatin 5 mg
Rosuzet 5/10 mg , once a day for 24 months
Drug: Ezetimibe 10mg + Rosuvastatin 5mg
Initial use of 10mg of ezetimibe combined with 5 mg of rosuvastatin
Other Names:
  • Rosuzet 10/5 mg
Active Comparator: rosuvastatin 20 mg only
Any brand drugs of rosuvastatin 20mg, once a day for 24 months
Drug: Rosuvastatin 20mg
20mg of Rosuvastatin as a standard treatment for AMI patients
Other Names:
  • Crestor 20mg

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Major Adverse Cardiovascular Events (MACE)
Time Frame: 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.
24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of Statin associated muscle symptoms
Time Frame: 3 months
Stain Associated Muscle Symptom questionnaire
3 months
death from any cause, a major coronary event, or a non-fatal stroke
Time Frame: 24 months
death from any cause, a major coronary event, or a non-fatal stroke
24 months
cardiovascular death, non-fatal MI, or non-fatal stroke
Time Frame: 24 months
cardiovascular death, non-fatal MI, or non-fatal stroke
24 months
all-cause death from any cause
Time Frame: 24months
24months
cardiovascular death
Time Frame: 24months
24months
any myocardial infaction
Time Frame: 24 months
24 months
any stroke
Time Frame: 24 months
24 months
any revascularization occurring at least 30 days after randomization
Time Frame: 24 months
24 months
LDL-C reduction <= 70mg/dl
Time Frame: 3 months
LDL cholesterol level of 70mg/dL or less
3 months
LDL-C reduction <= 55mg/dl
Time Frame: 3 months
3 months
drug discontinuation or dose reduction
Time Frame: 24 months
24 months
pill count drug adherence
Time Frame: 24 months
24 months
new onset diabetes
Time Frame: 24 months
24 months
cataract
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kiyuk Chang, MD,PhD

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Kiyuk Chang, MD,PhD, Seoul St. Mary's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 29, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 5, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 30, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ROSUZET-AMI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Aggregate summary data available on reasonable request. Exceptionally, and subject to Steering Committee approval, deidentified core analytic IPD may be accessed in a secure, non-downloadable virtual environment at the coordinating center. Contact PI (Kiyuk Chang) with proposal + ethics documentation; DUA required; costs may apply.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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