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Aggressive cholesterol drugs may shrink artery plaque in young patients

NCT ID NCT05783804

Disease control Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether starting strong cholesterol-lowering therapy early can reverse plaque buildup in the arteries of young adults (ages 18-50) with familial hypercholesterolemia, a genetic condition causing very high cholesterol. Researchers will use CT scans to measure changes in plaque volume over time. The goal is to see if aggressive treatment can stop or even reverse artery disease progression.

What this could mean

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

Active substance
lipid-lowering therapy (statins and/or other cholesterol drugs)
What this could lead to
If it works, this could show that early aggressive treatment can reverse artery plaque buildup, potentially reducing heart attack risk in young people with this genetic condition.
What could go wrong
This is a small early-phase study with only 60 participants, so results may not apply to everyone. Plaque reversal may be modest or not occur, and aggressive lipid-lowering carries risks like muscle pain or liver issues.

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.

Participants

About 60 people

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

Started

Jul 2022

Expected to finish

Apr 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.

Who is studied

Adult (newly diagnosed) heterozygous FH patients between 18 and 50 years with non-calcificated plaque on coronary CT angiography and who are not optimally treated yet.

Ages

18 to 50 years

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: * Diagnosed with heterozygous familial hypercholesterolemia * Adult between 18 and 50 years old * LDL cholesterol levels above 100 mg/dl (\>2.6 mmol/L) at inclusion Exclusion Criteria: * Renal insufficiency, defined as eGFR \< 30 ml/min * History of atherosclerotic cardiovascular events * Atrial fibrillation * Any other treatment or clinically relevant condition that could interfere with the conduct or interpretation of the study in the opinion of the investigator * Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study.

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Conditions

The condition(s) this trial relates to.

coronary artery disorder familial hypercholesterolemia

As listed by the trial registrant

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

Coronary artery disease progression

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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.

Contacts and locations

Locations

  • Amsterdam UMC, location AMC

    RECRUITING

    Amsterdam, North Holland, 1105 AZ, Netherlands

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