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New combo pill could offer safer cholesterol control for seniors

NCT ID NCT07626840

Disease control Sponsor: Samsung Medical Center Source: ClinicalTrials.gov ↗

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares a moderate statin (pitavastatin) combined with ezetimibe against high-intensity statins (atorvastatin or rosuvastatin) in patients aged 75+ with coronary artery disease who need a stent. The goal is to see if the combo is just as good at preventing heart attacks, strokes, and other major events, but with fewer side effects like muscle pain or diabetes risk. 5,000 participants will be followed after their procedure.

What this could mean

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

Active substance
Pitavastatin and ezetimibe combination (Livalozet 4/10mg)
What this could lead to
If successful, this could offer older heart patients a safer, equally effective cholesterol-lowering option with fewer side effects than high-intensity statins.
What could go wrong
This trial hasn't started yet and is large (5,000 participants), but it's testing non-inferiority, meaning the combo might not be better—just as good. Side effects like muscle pain or liver issues are still possible.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 5,000 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

75 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 * Age 75 years or older * Patients diagnosed with stable coronary artery disease or acute coronary syndrome and requiring coronary artery intervention due to coronary artery stenosis * Patients with primary hypercholesterolemia and mixed dyslipidemia * Patients who understand the risks and benefits of treatment, as well as alternatives, and can voluntarily sign the informed consent form Exclusion Criteria: * Patients with hypersensitivity or contraindications to statins or ezetimibe * Patients with active liver disease or persistently elevated AST or ALT levels exceeding three times the upper limit of normal * Patients with a history of organ transplantation (kidney, liver, etc.) * Pregnant or lactating women * Patients with a life expectancy of less than one year due to non-cardiac disease, or those deemed unable to participate in the study and follow-up (based on the medical judgment of the investigator at each site)

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Conditions

The condition(s) this trial relates to.

acute coronary syndrome coronary artery disorder

As listed by the trial registrant

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

Acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) Coronary artery disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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