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Primary PreventionPhase 4NCT06722521

GUIDE-CAC: Statin-Ezetimibe Without Aspirin vs. Statin Monotherapy With Aspirin in High Coronary Calcification

A Phase 4 study testing Pitavastatin 4mg and ezetimibe 10mg, taken once daily and Pitavastatin 2 mg with aspirin 100 mg, taken once daily. in people with Primary Prevention and Vascular Calcification, run by Asan Medical Center at 1 site in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

A Multicenter, randomized trial comparing the efficacy and safety of intensive lipid-lowering therapy using a statin-ezetimibe combination without aspirin versus statin monotherapy with aspirin in asymptomatic patients with coronary artery calcification Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Primary Prevention, Vascular Calcification
What is being tested?
Pitavastatin 4mg and ezetimibe 10mg, taken once daily and Pitavastatin 2 mg with aspirin 100 mg, taken once daily.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7,435 participants
Where
1 siteSouth Korea
Study dates
9 Jul 2025to 31 Oct 2032
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 years and older
  • Asymptomatic patients with significant coronary calcification (Agatston score ≥ 100) and no physiologically significant coronary artery disease (CAD)
  • The coronary CT scan used to establish the CAC score must be performed within 3 years prior to randomization.
  • The assessment of physiological significance must be performed within 6 months prior to randomization
  • Participants will be eligible for inclusion regardless of prior statin or anti-platelet agents use.

Who cannot join

  • Major ASCVD events (clinically documented ASCVD)
  • If at least one of the following criteria is present via patient history, physical examination, or medical records at the time of screening, the patient is not eligible:
  • Acute coronary syndrome (MI or unstable angina)
  • Coronary revascularization (PCI, CABG) or other arterial revascularization
  • Ischemic stroke (Not TIA)
  • Symptomatic peripheral arterial disease (history of claudication with ABI <0.90, or previous revascularization or amputation
Show all 24Show fewer
  • Patients with physiologically significant CAD
  • Moderate to severe CAD (diameter stenosis >50%) on CCTA with positive strest test (thallium, treadmil, stress echocardiography)
  • Moderate to severe CAD (diameter stenosis >50%) on CAG with positive fractional flow reserve (FFR) < 0.8
  • Patients with familial hypercholesterolemia.
  • Patients with low-density lipoproteins cholesterol (LDL-C) ≥ 190 mg/dL regardless taking a statin or not.
  • Continuation of PCSK9 inhibitor is required during the clinical trial
  • Patients with chronic kidney disease (<eGFR 30mL/min/1.73m2)
  • Advanced liver disease (Child-Pugh B or C)
  • Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (ALT or AST > 5 times upper limit of normal).
  • History of gastrointestinal bleeding, peptic ulcer, or intracranial hemorrhage within 6 months prior screening
  • Patients with a history of organ transplantation who are on immunosuppressive therapy
  • Concurrent use of other medications that may increase bleeding risk such NOAC and warfarin
  • A history of significant allergic reaction to aspirin or statin/ezetimibe
  • A diagnosis of cancer (other than superficial squamous or basal cell skin cancer) in the past 3 years or current treatment for the active cancer.
  • Life expectancy < 1 years for any non-cardiac or cardiac causes.
  • Patient's pregnant or breast-feeding or child-bearing potential.
  • Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study.
  • Unwillingness or inability to comply with the procedures described in this protocol

Trial locations and contacts

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

Seung-Whan Lee contact

82230103170

seungwlee@amc.seoul.kr

South Korea1 site, 1 recruiting

  • Asan Medical Center

    Seoul

    Seung-Whan Lee, MD, seungwlee@amc.seoul.kr

    Tae Oh Kim, MD, allldie_7@naver.com

    Recruiting

Other trials in South Korea

About this study

Official title: Comparison of Intensive Lipid-Lowering Therapy With a Statin-Ezetimibe Combination (Without Aspirin) vs. Statin Monotherapy (With Aspirin) In Asymptomatic Patient With Coronary Artery Calcification

A Multicenter, randomized trial comparing the efficacy and safety of intensive lipid-lowering therapy using a statin-ezetimibe combination without aspirin versus statin monotherapy with aspirin in asymptomatic patients with coronary artery calcification

Read the detailed description

Coronary artery calcification is a well-established marker of subclinical atherosclerosis that effectively identifies high-risk individuals for cardiovascular events, even in asymptomatic patients. However, the optimal intensity of preventive interventions-particularly regarding the balance between efficacy and safety-remains unclear in asymptomatic patients with significant coronary calcification.

While aspirin has traditionally been used for the primary prevention of cardiovascular events, recent evidence suggests that its routine use in asymptomatic individuals may carry greater bleeding risks than cardiovascular benefits. In contrast, intensive lipid-lowering therapy with statins and ezetimibe has proven effective in reducing LDL-C levels and preventing cardiovascular events by slowing atherosclerotic progression and stabilizing plaques.

This study aims to evaluate whether intensive lipid-lowering therapy using a statin-ezetimibe combination (without aspirin) is non-inferior to statin monotherapy (with aspirin) in reducing cardiovascular events among patients with significant coronary artery calcification. By comparing these two strategies, we seek to establish whether more aggressive lipid management might obviate the need for aspirin in these intermediate- to high-risk yet asymptomatic patients.

Being tested
Pitavastatin 4mg and ezetimibe 10mg, taken once daily, Pitavastatin 2 mg with aspirin 100 mg, taken once daily.
Keywords
Cardiovascular Diseases, Aspirin, Statin
Medical subject headings
Vascular Calcification, Cardiovascular Diseases

What participants receive

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

  • Pitavastatin 4mg and ezetimibe 10mg, taken once dailyDrug

    Intensive lipid-lowering therapy without aspirin

  • Pitavastatin 2 mg with aspirin 100 mg, taken once daily.Drug

    Moderate-intensity lipid-lowering therapy with aspirin

Study groups in NCT06722521
Study groupRoleWhat they receive
Intensive lipid-lowering therapy without aspirinExperimentalIn this group, intensive lipid-lowering therapy is performed without aspirin using pitavastatin 4 mg/ezetimibe 10 mg, targeting patients with coronary artery calcification (Agatston score ≥100) who require primary prevention and do not have physiologically significant coronary artery disease. ◦ Intervention Medications: Pitavastatin 4 mg/ezetimibe 10 mg (aspirin excluded)
Receives: Drug: Pitavastatin 4mg and ezetimibe 10mg, taken once daily
Statin Monotherapy with AspirinActive comparatorIIn this group, moderate-intensity lipid-lowering therapy is administered using pitavastatin 2 mg and aspirin for patients with coronary artery calcification (Agatston score ≥100) who require primary prevention and do not have physiologically significant coronary artery disease. ◦ Intervention Medications: Pitavastatin 2 mg and aspirin (Based on the clinician's judgment, the statin dosage may be increased to pitavastatin 4 mg depending on the LDL response, and if there are adverse effects associated with aspirin, it can be replaced with clopidogrel.)
Receives: Drug: Pitavastatin 2 mg with aspirin 100 mg, taken once daily.

What is being measured

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

  1. Event rate of a major adverse cardiovascular events

    Death from any cause, myocardial infarction, stroke, urgent coronary revascularization, resuscitated cardiac arrest, or unstable angina related hospitalization

    Measured: 48months

Secondary outcomes (11)

  1. Event rate of a all cause death

    All-cause mortality was used instead of cardiac mortality to avoid potentially difficult adjudication of causes of death, especially given the relatively low expected mortality rate. In addition, the cause of death will be adjudicated as being due to cardiovascular causes, non-cardiovascular causes, or undetermined causes.

    Measured: 48months

  2. Event rate of a cardiovascular death

    includes death resulting from an acute myocardial infarction (MI), sudden cardiac death, death due to heart failure (HF), death due to stroke, death due to cardiovascular (CV) procedures, death due to CV hemorrhage, and death due to other CV causes

    Measured: 48months

  3. Event rate of a spontaneous myocardial infarction

    A spontaneous myocardial infarction related to atherosclerotic plaque rupture, ulceration, fissuring, erosion, or dissection, resulting in intraluminal thrombus in one or more of the coronary arteries

    Measured: 48months

  4. Event rate of a stroke

    1. Ischemic Stroke B. Hemorrhagic Stroke C. Undetermined Stroke

    Measured: 48months

  5. Event rate of a urgent coronary revascularization

    1. Elective:
    2. Urgent:
    3. Emergency:
    4. Salvage:

    Measured: 48months

  6. Event rate of a Resuscitated cardiac arrest

    Measured: 48months

  7. Event rate of a unstable angina related hospitalization

    Measured: 48months

  8. Event rate of a composite of hard outcomes (all cause death, myocardial infarction and ischemic stroke)

    Measured: 48months

  9. Event rate of a Clinically relevant bleeding (Bleeding Academic Research Consortium definition ≥ type 2)

    Bleeding Academic Research Consortium definition ≥ type 2

    Measured: 48months

  10. Changes of Lipid profile

    Measured: 48months

  11. Treatment-emergent Serious Adverse Events resulting in Study Drug Discontinuation

    Liver function abnormalities(AST or ALT > 5x ULN)

    Renal function abnormalities (serum creatinine increase ≥3-fold from baseline OR increase to ≥4.0 mg/dL OR initiation of renal replacement therapy)

    Muscle-related events (Statin-associated muscle symptoms OR CK >5x ULN) (CK reference range: 50-250 IU/L)

    Measured: 48months

Timeline

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

  1. First posted9 Dec 2024
  2. Study start9 Jul 2025
  3. Primary completion30 Jun 2032 (estimated)
  4. Study completion31 Oct 2032 (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
7,435 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06722521
Sponsor's protocol ID
2025-0193
Status last verified
Aug 2025
First submitted
4 Dec 2024
Last updated
7 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Pitavastatin 4mg and ezetimibe 10mg, taken once daily and Pitavastatin 2 mg with aspirin 100 mg, taken once daily. in people with Primary Prevention and Vascular Calcification, run by Asan Medical Center at 1 site 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 5 inclusion and 24 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 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 Seung-Whan Lee (82230103170, seungwlee@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Event rate of a major adverse cardiovascular events (time frame: 48months). 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 NCT06722521.

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 7 Aug 2025.

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