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Can lowering cholesterol more aggressively help seniors with heart disease?

NCT ID NCT05361421

Disease control Sponsor: Yonsei University 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 two cholesterol-lowering strategies in adults aged 75 and older who have heart or blood vessel disease. One group aims for a very low LDL cholesterol target (below 55 mg/dL) using high-intensity statins, while the other receives standard moderate-intensity statin therapy. The goal is to see if the more aggressive approach reduces the risk of heart-related death, heart attacks, strokes, or the need for procedures to open blocked arteries.

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

About 1,200 people

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

Started

Jul 2022

Expected to finish

Oct 2027

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 1. Age ≥75 years 2. Documented atherosclerotic cardiovascular disease (at least 1 of the following) A. Previous acute coronary syndrome (MI or unstable angina) B. Or stable angina with imaging studies of coronary artery disease or functional studies of myocardial ischemia C. Or coronary revascularization (percutaneous coronary intervention or coronary artery bypass graft) D. Or peripheral artery disease. Exclusion criteria 1. MI or stroke within 1 year 2. LDL-cholesterol level less than 55 mg/dL without statin therapy 3. Active liver disease or persistent unexplained serum AST/ALT elevation more than 2 times the upper limit of normal range 4. Allergy or hypersensitivity to any statin 5. Life expectancy less than 1 years 6. Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator

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Conditions

The condition(s) this trial relates to.

atherosclerotic cardiovascular disease cardiovascular disorder

As listed by the trial registrant

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

Cardiovascular disease

Contacts and locations

Locations

  • Yonsei University Health System, Severance Hospital

    Seoul, South Korea

More trials for these conditions

Other studies related to the condition(s) this trial covers.