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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ezetimibe 10 mg plus rosuvastatin 5 mg | Experimental | Rosuzet 5/10 mg , once a day for 24 months |
|
| rosuvastatin 20 mg only | Active Comparator | Any brand drugs of rosuvastatin 20mg, once a day for 24 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ezetimibe 10mg + Rosuvastatin 5mg | Drug | Initial use of 10mg of ezetimibe combined with 5 mg of rosuvastatin |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 24 months |
| cardiovascular death, non-fatal MI, or non-fatal stroke |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kiyuk Chang, MD,PhD | Contact | 82-10-9175-2076 | kiyuk@catholic.ac.kr | |
| Eun Ho Choo, MD | Contact | 82-10-8500-4569 | cmcchu@catholic.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Kiyuk Chang, MD,PhD | Seoul St. Mary's Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bucheon St.Mary Hospital | Recruiting | Bucheon-si | Gyeonggido | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41198200 | Derived | 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. |
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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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| Rosuvastatin 20mg | Drug | 20mg of Rosuvastatin as a standard treatment for AMI patients |
|
|
cardiovascular death, non-fatal MI, or non-fatal stroke
| 24 months |
| all-cause death from any cause | 24months |
| cardiovascular death | 24months |
| any myocardial infaction | 24 months |
| any stroke | 24 months |
| any revascularization occurring at least 30 days after randomization | 24 months |
| LDL-C reduction <= 70mg/dl | LDL cholesterol level of 70mg/dL or less | 3 months |
| LDL-C reduction <= 55mg/dl | 3 months |
| Rate of Statin associated muscle symptoms | Stain Associated Muscle Symptom questionnaire | 3 months |
| drug discontinuation or dose reduction | 24 months |
| pill count drug adherence | 24 months |
| new onset diabetes | 24 months |
| cataract | 24 months |
| St.Vincent's Hospital | Recruiting | Suwon | Gyeonggido | South Korea |
|
| Uijeongbu St.Mary's Hospital | Recruiting | Uijeongbu-si | Gyeonggido | South Korea |
|
| Daejeon St.Mary's Hospital | Recruiting | Daejeon | South Korea |
|
| Incheon St.Mary's Hospital | Recruiting | Incheon | South Korea |
|
| Seoul St.Mary's Hospital | Recruiting | Seoul | 137-701 | South Korea |
|
| Yeouido St.Mary Hospital | Recruiting | Seoul | South Korea |
|
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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| ID | Term |
|---|---|
| D000069438 | Ezetimibe |
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D001384 | Azetidines |
| D001385 | Azetines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
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