A Phase 4 interventional study of Crezet 2.5/10mg and Litorvazet 5/10mg in Atherosclerosis Cardiovascular Disease, sponsored by Yonsei University. Not yet recruiting at 2 sites in South Korea. Open to participants aged 30 Years to 79 Years. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Yonsei University · Phase 4, Interventional, and Treatment
This study aims to compare the tolerability and metabolic safety of three low-dose statin/ezetimibe combinations (rosuvastatin/ezetimibe 2.5/10 mg, atorvastatin/ezetimibe 5/10 mg, pitavastatin/ezetimibe 1/10 mg) in patients with minimal subclinical atherosclerosis identified by imaging studies (Coronary Computed Tomography Angiography, Coronary Angiography, or carotid sonography)
This study compares three low-dose statin/ezetimibe combination drugs (rosuvastatin/ezetimibe 2.5/10 mg, atorvastatin/ezetimibe 5/10 mg, pitavastatin/ezetimibe 1/10 mg) currently marketed in Korea in a randomized trial of patients with minimal subclinical atherosclerosis.
By using 'drug discontinuation/reduction due to intolerance' as the primary endpoint, we aim to evaluate clinically meaningful tolerability in the field, while also assessing NODM(New-Onset Diabetes Mellitus) occurrence, HbA1c changes, LDL-C target attainment, and drug adherence to provide a clinical rationale for a 'personalized low-dose lipid-lowering strategy.'
Yonsei University is the lead sponsor of 1,410 studies on the registry; 235 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients with video-confirmed minimal subclinical atherosclerosis who meet one or more of the following criteria:
Those eligible for reimbursement for statin/ezetimibe combination therapy at the time of registration, in accordance with the domestic guidelines for dyslipidemia treatment. In other words, the LDL-C reimbursement initiation criteria based on the patient's cardiovascular risk classification
LDL-C ≥ 160 mg/dL with one major cardiovascular risk factor Registration will proceed only for those who meet the above salary criteria Table. Major Cardiovascular Risk Factors Category Major Cardiovascular Risk Factor Criteria
Exclusion Criteria:
participants receive Rosuvastatin/ezetimibe 2.5/10mg (Crezet 2.5/10mg)
Drug: Crezet 2.5/10mg
participants receive Atorvastatin/ezetimibe 5/10mg (Litorvazet 5/10mg)
Drug: Litorvazet 5/10mg
participants receive Pitavastatin/ezetimibe 1/10mg (Baroezet 1/10mg)
Drug: Baroezet 1/10mg
Participants will take 1 tablet of Rosuvastatin/ezetimibe 2.5/10mg(Crezet 2.5/10mg) orally once daily for 12 months
Participants will take 1 tablet of Atorvastatin/ezetimibe 5/10mg (Litorvazet 5/10mg) orally once daily for 12 months
Participants will take 1 tablet of Pitavastatin/ezetimibe 1/10mg (Baroezet 1/10mg) orally once daily for 12 months
discontinuation or drug change of the study drug due to intolerance
Incidence rate of "discontinuation or drug change of the study drug due to intolerance" up to one year in time
Time frame: Verified for 1 year after registration
NODM(New-Onset Diabetes Mellitus)
NODM(New-Onset Diabetes Mellitus): Defined as HbA1c ≥ 6.5% (FPG ≥ 126 mg/dL is excluded from the diagnostic criteria)
Time frame: Verified for 1 year after registration
HbA1c
12-month change in HbA1c compared to baseline
Time frame: Check after 12 months of registration
LDL-C target achievement rate
LDL-C target achievement rate (target achievement rate: LDL-C \< 100 mg/dL Criteria)
Time frame: Check after 12 months of registration
LDL-C levels
LDL-C levels for 12 months
Time frame: Check after 12 months of registration
MPR(Medication possession ratio)
Medication possession ratio (MPR(Medication Possession Ratio) - total number of days of prescription or dispensing / observing institution): rate of achievement of 80% or higher and average MPR(Medication Possession Ratio)
Time frame: Verified for 12 months after registration
Adverse Event (AE) incidence
Adverse Event (AE) incidence: elevated AST/ALT, elevated CPK, SAMS, myopathy, rhabdomyolysis, and other adverse drug reactions
Time frame: Verified for 12 months after registration
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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