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Cholesterol combo pill shows promise for High-Risk hearts

NCT ID NCT05761444

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested whether adding ezetimibe to atorvastatin (a common cholesterol drug) works better than atorvastatin alone in people at very high risk for heart attacks or strokes. Researchers enrolled 137 adults with atherosclerotic cardiovascular disease and measured how much their LDL (bad) cholesterol dropped after 6 weeks. The goal was to see if the combination pill helps more patients reach their cholesterol target.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ezetimibe and atorvastatin combination tablet
What this could lead to
If it works, this could support using a combination pill as a standard early treatment to better control cholesterol in people at very high risk of heart problems.
What could go wrong
This is a small, completed Phase 4 trial (137 people) that only measured short-term cholesterol changes, not long-term heart attack or stroke prevention. Results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

137 people

The number who actually took part.

Started

Jul 2023

Finished

Oct 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients who are ≥ 30 years old. 2. Patients with very high-risk\*: clinical or unequivocal on imaging ASCVD. ASCVD includes previous ACS (MI or UA), stable angina, coronary revascularization (percutaneous coronary intervention (PCI), coronary artery bypass graft surgery (CABG), and other arterial revascularization procedures), stroke and transient ischaemic attack (TIA), and peripheral arterial disease (Mach F 2020). 3. Patients (a) who failed to achieve their target LDL-C goals with low and/or moderate intensity statin mono therapy for ≥ 4 weeks or (b) who are statin-naïve or have not been on a stable (unchanged) statin regimen for at least 4 weeks prior to enrollment * rosuvastatin \< 10 mg, atorvastatin \< 40 mg, and all dose of pitavastatin, simvastatin, lovastatin, pravastatin, and fluvastatin (Team G 2020). 4. Patients with LDL-C levels ≥ 70 mg/dL 5. Patients who are willing to maintain TLC throughout the study. 6. Patients who are willing to provide written informed consent prior to study enrollment. Exclusion Criteria: 1. Patients with hypersensitivity to ezetimibe, atorvastatin or any of its inactive ingredients. 2. Patients with active liver disease or unexplained persistent elevations of hepatic transaminase levels. (aspartate transaminase (AST) or alanine transaminase (ALT) \> 3 x upper limit of normal (ULN)). 3. Patients who have predisposing conditions with muscle disease (i.e., rhabdomyolysis or myopathy) or neuromuscular disease. 4. Patients with myasthenia gravis. 5. Female patients who are pregnant or have a potential to be pregnant and nursing. 6. Patients who are taking glecaprevir and pibrentasvir. 7. Patients with hereditary problems of galactose intolerance, lapp lactase deficiency, or of glucose-galactose malabsorption. 8. Patients with disease known to influence serum lipids or lipoproteins excluding dyslipidemia. 9. Patients with a history of cancer within 5 years. 10. Patients whose life expectancy is less than 6 months due to their medical conditions. 11. Patients with any condition or situation that might pose a risk to the participant or interfere with participation in the study. 12. Patients who have received any investigational medicine within 12 weeks of written informed consent or are going to receive during the clinical trial period. 13. Patients who are judged to be difficult to conduct clinical trials according to the judgment of the investigator.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Chonnam National University Hospital

    Gwangju, Jeollanam-do, 61469, South Korea

  • Eunpyeong St. Mary's Hospital

    Seoul, Eunpyeong-gu, 03312, South Korea

  • Inje University Ilsan-Paik Hospital

    Goyang-si, Gyeonggi-do, 10380, South Korea

  • Kangbuk Samsung Hospital

    Seoul, 03181, South Korea

  • Keimyung University Dongsan Medical Center

    Daegu, Gyeongsangbuk-do, 42601, South Korea

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620, South Korea

  • Ulsan University Hospital

    Ulsan, Gyeongsangnam-do, 44033, South Korea

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