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Not yet recruitingNCT07871604MINI-STARUpdated Oct 16, 2026

Feasibility of Combination Therapy With Low-dose Statin and Ezetimibe in Patients With Minimal Subclinical Atherosclerosis

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

Updated Oct 16, 2026Eligibility revisedNewly registeredGo to Updates ↓
Phase
Phase 4
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
30 Years to 79 Years
Sex
All
01

Study summary

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)

Read the detailed description

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.'

02

Conditions studied

  • Atherosclerosis Cardiovascular Disease

Keywords

  • minimal subclinical atherosclerosis
  • combination therapy with low-dose statin and ezetimibe
03

In context

Lead sponsor

Yonsei University is the lead sponsor of 1,410 studies on the registry; 235 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  1. Adult men and women between the ages of 30 and 79
  2. Patients with video-confirmed minimal subclinical atherosclerosis who meet one or more of the following criteria:

    • Minimal subclinical coronary artery disease with less than 30% coronary artery stenosis on CCTA or CAG
    • Individuals with a coronary artery calcification index (CACS/CCS) between 0 and less than 100
    • Patients with carotid plaque detected on carotid ultrasound (diameter stenosis less than 30%) or intima-media thickness (IMT) of 1.5 mm or more, or a protrusion of 0.5 mm or more
  3. 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

    • Two or more major cardiovascular risk factors, and LDL-C ≥ 130 mg/dL
    • 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

      1. Age Male ≥ 45 years old, Female ≥ 55 years old
      2. Family history of early onset of coronary artery disease onset in men at 55 and women at 65
      3. hypertension If hypertension is present
      4. Smoker Current Smoker
      5. Low HDL-C \< 40mg/dL Deduction: If high HDL-C (protective factor) is ≥ 60 mg/dL, deduct 1 from the number of risk factors
  4. Those who have voluntarily given written consent to participate in this clinical study

Exclusion criteria

Exclusion Criteria:

  1. Individuals diagnosed with existing diabetes (Type 1 or Type 2 DM): HbA1c ≥ 6.5% or those taking diabetes medications (oral hypoglycemic agents or insulin)
  2. Individuals with a coronary artery calcification index (CACS) of 100 or higher
  3. Individuals with coronary artery stenosis of 30% or more on a CCTA or CAG
  4. Individuals whose LDL-C levels are below the initiation criteria based on the number of major cardiovascular risk factors
  5. Individuals classified as high-risk or ultra-high-risk (For example: acute coronary syndrome or PCI within the past year, or LDL-C target recommended \<55-70 mg/dL)
  6. Persons with active liver disease or AST/ALT levels at or above three times the upper limit of the normal range
  7. Severe chronic renal impairment (eGFR \<30 mL/min/1.73m² or dialysis)
  8. Individuals who are hypersensitive to statins or the ingredient ezetimibe
  9. Pregnant women, nursing women, or women of childbearing age who have difficulty using appropriate contraception
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    Rosuvastatin/ezetimibe 2.5/10mg

    participants receive Rosuvastatin/ezetimibe 2.5/10mg (Crezet 2.5/10mg)

    Drug: Crezet 2.5/10mg

  • Experimental
    Atorvastatin/ezetimibe 5/10mg

    participants receive Atorvastatin/ezetimibe 5/10mg (Litorvazet 5/10mg)

    Drug: Litorvazet 5/10mg

  • Experimental
    Pitavastatin/ezetimibe 1/10mg

    participants receive Pitavastatin/ezetimibe 1/10mg (Baroezet 1/10mg)

    Drug: Baroezet 1/10mg

Interventions

  • DrugCrezet 2.5/10mg

    Participants will take 1 tablet of Rosuvastatin/ezetimibe 2.5/10mg(Crezet 2.5/10mg) orally once daily for 12 months

  • DrugLitorvazet 5/10mg

    Participants will take 1 tablet of Atorvastatin/ezetimibe 5/10mg (Litorvazet 5/10mg) orally once daily for 12 months

  • DrugBaroezet 1/10mg

    Participants will take 1 tablet of Pitavastatin/ezetimibe 1/10mg (Baroezet 1/10mg) orally once daily for 12 months

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. HbA1c

    12-month change in HbA1c compared to baseline

    Time frame: Check after 12 months of registration

  3. 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

  4. LDL-C levels

    LDL-C levels for 12 months

    Time frame: Check after 12 months of registration

  5. 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

  6. 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

07

Study locations

2 sites
  • Yongin Severance Hospital, Yonsei University College of Medicine
    Yongin-si, Gyeonggi-do 16995, South Korea
  • Yongin Severance Hospital, Yonsei University College of Medicine
    Yongin-si, Gyeonggi-do 16995, South Korea
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

2 registry updates since Sep 25, 2026
Also revised
eligibility
Registered
First appeared on the registry
Oct 13, 2026
Show all 2 updates
  1. Oct 16, 2026
    Eligibility Criteria revised
    + 2 other changes: description and secondary outcomes
  2. Oct 13, 2026
    First appeared on the registry

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 ↗

10

Registry details

Key details

Study ID
NCT07871604
Lead sponsor
Yonsei University
Responsible party
Yongcheol Kim (Professor (Devision of Cardiology), Yonsei University) — Principal investigator
First posted
Oct 13, 2026
Start date
Nov 10, 2026 (estimated)
Primary completion
Sep 21, 2029 (estimated)
Completion
Sep 21, 2029 (estimated)
Last update
Oct 16, 2026

Study contacts

Yongcheol Kim, MD,PhD
Contact
yongcheol@yuhs.ac
821058084029

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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