AzTrials
AzTrials

Atherosclerosis Cardiovascular DiseasePhase 4MINI-STARNCT07871604

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

A Phase 4 study testing Crezet 2.5/10mg, Litorvazet 5/10mg and Baroezet 1/10mg in people with Atherosclerosis Cardiovascular Disease, run by Yonsei University at 2 sites in South Korea.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 30 to 79 years
Conditions the study is for
Atherosclerosis Cardiovascular Disease
What is being tested?
Crezet 2.5/10mg, Litorvazet 5/10mg and Baroezet 1/10mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
2 sitesSouth Korea
Study dates
10 Nov 2026to 21 Sep 2029
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 30 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult men and women between the ages of 30 and 79
  • 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
  • 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
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  • 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
  • Age Male ≥ 45 years old, Female ≥ 55 years old
  • Family history of early onset of coronary artery disease onset in men at 55 and women at 65
  • hypertension If hypertension is present
  • Smoker Current Smoker
  • Low HDL-C < 40mg/dL Deduction: If high HDL-C (protective factor) is ≥ 60 mg/dL, deduct 1 from the number of risk factors
  • Those who have voluntarily given written consent to participate in this clinical study

Who cannot join

  • Individuals diagnosed with existing diabetes (Type 1 or Type 2 DM): HbA1c ≥ 6.5% or those taking diabetes medications (oral hypoglycemic agents or insulin)
  • Individuals with a coronary artery calcification index (CACS) of 100 or higher
  • Individuals with coronary artery stenosis of 30% or more on a CCTA or CAG
  • Individuals whose LDL-C levels are below the initiation criteria based on the number of major cardiovascular risk factors
  • 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)
  • Persons with active liver disease or AST/ALT levels at or above three times the upper limit of the normal range
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  • Severe chronic renal impairment (eGFR <30 mL/min/1.73m² or dialysis)
  • Individuals who are hypersensitive to statins or the ingredient ezetimibe
  • Pregnant women, nursing women, or women of childbearing age who have difficulty using appropriate contraception

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Yongcheol Kim, MD,PhD contact

821058084029

yongcheol@yuhs.ac

South Korea2 sites

  • Yongin Severance Hospital, Yonsei University College of Medicine

    Yongin-si, Gyeonggi-do, 16995

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

  • Yongin Severance Hospital, Yonsei University College of Medicine

    Yongin-si, Gyeonggi-do, 16995

Other trials in South Korea

About this study

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.'

Being tested
Crezet 2.5/10mg, Litorvazet 5/10mg, Baroezet 1/10mg
Keywords
minimal subclinical atherosclerosis, combination therapy with low-dose statin and ezetimibe

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Crezet 2.5/10mgDrug

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

  • Litorvazet 5/10mgDrug

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

  • Baroezet 1/10mgDrug

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

Study groups in NCT07871604
Study groupRoleWhat they receive
Rosuvastatin/ezetimibe 2.5/10mgExperimentalparticipants receive Rosuvastatin/ezetimibe 2.5/10mg (Crezet 2.5/10mg)
Receives: Drug: Crezet 2.5/10mg
Atorvastatin/ezetimibe 5/10mgExperimentalparticipants receive Atorvastatin/ezetimibe 5/10mg (Litorvazet 5/10mg)
Receives: Drug: Litorvazet 5/10mg
Pitavastatin/ezetimibe 1/10mgExperimentalparticipants receive Pitavastatin/ezetimibe 1/10mg (Baroezet 1/10mg)
Receives: Drug: Baroezet 1/10mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Verified for 1 year after registration

Secondary outcomes (6)

  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)

    Measured: Verified for 1 year after registration

  2. HbA1c

    12-month change in HbA1c compared to baseline

    Measured: 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)

    Measured: Check after 12 months of registration

  4. LDL-C levels

    LDL-C levels for 12 months

    Measured: 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)

    Measured: 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

    Measured: Verified for 12 months after registration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2026
  2. Study start10 Nov 2026 (estimated)
  3. Primary completion21 Sep 2029 (estimated)
  4. Study completion21 Sep 2029 (estimated)

Resources

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
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07871604
Sponsor's protocol ID
9-2026-0183
Acronym
MINI-STAR
Status last verified
Oct 2026
First submitted
6 Oct 2026
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Crezet 2.5/10mg, Litorvazet 5/10mg and Baroezet 1/10mg in people with Atherosclerosis Cardiovascular Disease, run by Yonsei University at 2 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 14 inclusion and 9 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: opening soon, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 Yongcheol Kim, MD,PhD (821058084029, yongcheol@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

discontinuation or drug change of the study drug due to intolerance (time frame: Verified for 1 year after registration). 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 NCT07871604.

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 16 Oct 2026.

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