Myocardial InfarctionPhase 4ROSUZET-AMINCT04499859
Low Dose Rosuvastatin Plus Ezetimibe Versus High-dose Rosuvastatin in AMI
A Phase 4 study testing Ezetimibe 10mg + Rosuvastatin 5mg and Rosuvastatin 20mg in people with Myocardial Infarction and Statin Adverse Reaction, run by Kiyuk Chang, MD,PhD at 7 sites in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Myocardial Infarction, Statin Adverse Reaction, HMG-CoA Reductase Inhibitor Toxicity
- What is being tested?
- Ezetimibe 10mg + Rosuvastatin 5mg and Rosuvastatin 20mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,548 participants
- Where
- 7 sitesSouth Korea
- Study dates
- 1 Oct 2020to 30 Aug 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
South Korea7 sites, 7 recruiting
- Recruiting
Bucheon St.Mary Hospital
Bucheon-si, Gyeonggido
Hee Yeol Kim, M.D.
- Recruiting
Daejeon St.Mary's Hospital
Daejeon
Man Won Park, M.D.
- Recruiting
Incheon St.Mary's Hospital
Incheon
Doo Soo Jeon, M.D.
- Recruiting
Seoul St.Mary's Hospital
Seoul, 137-701
Kiyuk Chang, M.D.
- Recruiting
Yeouido St.Mary Hospital
Seoul
Chul-Soo Park, M.D.
- Recruiting
St.Vincent's Hospital
Suwon, Gyeonggido
Ki-Dong Yoo, M.D.
- Recruiting
Uijeongbu St.Mary's Hospital
Uijeongbu-si, Gyeonggido
Chan Joon Kim, M.D.
About this study
Official title: 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.
Read the 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.
- Being tested
- Ezetimibe 10mg + Rosuvastatin 5mg, Rosuvastatin 20mg
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ezetimibe 10mg + Rosuvastatin 5mgDrug
Also called Rosuzet 10/5 mg
Initial use of 10mg of ezetimibe combined with 5 mg of rosuvastatin
Rosuvastatin 20mgDrug
Also called Crestor 20mg
20mg of Rosuvastatin as a standard treatment for AMI patients
| Study group | Role | What they receive |
|---|---|---|
| ezetimibe 10 mg plus rosuvastatin 5 mg | Experimental | Rosuzet 5/10 mg , once a day for 24 months Receives: Drug: Ezetimibe 10mg + Rosuvastatin 5mg |
| rosuvastatin 20 mg only | Active comparator | Any brand drugs of rosuvastatin 20mg, once a day for 24 months Receives: Drug: Rosuvastatin 20mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiovascular Events (MACE)
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.
Measured: 24 months
Secondary outcomes (14)
death from any cause, a major coronary event, or a non-fatal stroke
death from any cause, a major coronary event, or a non-fatal stroke
Measured: 24 months
cardiovascular death, non-fatal MI, or non-fatal stroke
cardiovascular death, non-fatal MI, or non-fatal stroke
Measured: 24 months
all-cause death from any cause
Measured: 24months
cardiovascular death
Measured: 24months
any myocardial infaction
Measured: 24 months
any stroke
Measured: 24 months
any revascularization occurring at least 30 days after randomization
Measured: 24 months
LDL-C reduction <= 70mg/dl
LDL cholesterol level of 70mg/dL or less
Measured: 3 months
LDL-C reduction <= 55mg/dl
Measured: 3 months
Rate of Statin associated muscle symptoms
Stain Associated Muscle Symptom questionnaire
Measured: 3 months
drug discontinuation or dose reduction
Measured: 24 months
pill count drug adherence
Measured: 24 months
new onset diabetes
Measured: 24 months
cataract
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start1 Oct 2020
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,548 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kiyuk Chang, MD,PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kiyuk Chang, MD,PhD, The Catholic University of Korea
- Investigators
- Kiyuk Chang, MD,PhD, Study chair, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04499859
- Sponsor's protocol ID
- ROSUZET-AMI
- Acronym
- ROSUZET-AMI
- Status last verified
- Jul 2025
- First submitted
- 29 Jul 2020
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Choo EH, Kim CJ, Hwang BH, Lee KY, Oh GC, Lim S, Choi IJ, Kim DB, Kwon OS, Lee S, Choi Y, Park CS, Park MW, Kim HY, Lee HC, Kang TS, Sung JK, Woo SI, Park HS, Yun KH, Chang K; ROSUZET-AMI investigator. 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. BMJ Open. 2025 Nov 5;15(11):e104127. doi: 10.1136/bmjopen-2025-104127.
PubMed 41198200
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04499859
- Acronym / sponsor ID
- ROSUZET-AMI / ROSUZET-AMI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,548 participants (estimated)
- Lead sponsor
- Kiyuk Chang, MD,PhDUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 5 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ezetimibe 10 mg plus rosuvastatin 5 mg | Experimental | Drug: Ezetimibe 10mg + Rosuvastatin 5mgRosuzet 5/10 mg , once a day for 24 months |
| rosuvastatin 20 mg only | Active comparator | Drug: Rosuvastatin 20mgAny brand drugs of rosuvastatin 20mg, once a day for 24 months |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ezetimibe 10mg + Rosuvastatin 5mgAlso: Rosuzet 10/5 mgInitial use of 10mg of ezetimibe combined with 5 mg of rosuvastatin | Drug | ezetimibe 10 mg plus rosuvastatin 5 mg |
| Rosuvastatin 20mgAlso: Crestor 20mg20mg of Rosuvastatin as a standard treatment for AMI patients | Drug | rosuvastatin 20 mg only |
Primary outcome
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.
14 secondary outcomes
death from any cause, a major coronary event, or a non-fatal stroke
Time frame: 24 months
cardiovascular death, non-fatal MI, or non-fatal stroke
Time frame: 24 months
all-cause death from any cause
Time frame: 24months
cardiovascular death
Time frame: 24months
any myocardial infaction
Time frame: 24 months
any stroke
Time frame: 24 months
any revascularization occurring at least 30 days after randomization
Time frame: 24 months
LDL-C reduction <= 70mg/dl
Time frame: 3 months
LDL-C reduction <= 55mg/dl
Time frame: 3 months
Rate of Statin associated muscle symptoms
Time frame: 3 months
drug discontinuation or dose reduction
Time frame: 24 months
pill count drug adherence
Time frame: 24 months
new onset diabetes
Time frame: 24 months
cataract
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Derived from this study: PubMed 41198200Choo EH, Kim CJ, Hwang BH, Lee KY, Oh GC, Lim S, Choi IJ, Kim DB, Kwon OS, Lee S, Choi Y, Park CS, Park MW, Kim HY, Lee HC, Kang TS, Sung JK, Woo SI, Park HS, Yun KH, Chang K; ROSUZET-AMI investigator. 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. BMJ Open. 2025 Nov 5;15(11):e104127. doi: 10.1136/bmjopen-2025-104127.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kiyuk Chang, MD,PhD study chair
Seoul St. Mary's Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ezetimibe 10mg + Rosuvastatin 5mg and Rosuvastatin 20mg in people with Myocardial Infarction and Statin Adverse Reaction, run by Kiyuk Chang, MD,PhD at 7 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kiyuk Chang, MD,PhD (82-10-9175-2076, kiyuk@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiovascular Events (MACE) (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04499859, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.