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Could a cholesterol drug help Kids' hearts after kawasaki disease?

NCT ID NCT07530640

Disease control Sponsor: Children's Hospital of Fudan University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase 3 trial is testing whether atorvastatin, a common cholesterol drug, is safe and can reduce inflammation in children with Kawasaki disease who also have coronary artery abnormalities. The study will enroll 9 children and give them different doses of atorvastatin for 6 weeks. Researchers will monitor side effects and measure changes in inflammation markers.

What this could mean

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

Active substance
atorvastatin (a statin drug, typically used to lower cholesterol)
What this could lead to
If it works, this could point toward a way to reduce heart artery damage in children with Kawasaki disease.
What could go wrong
This is a very small, early-phase trial (only 9 participants) focused on safety, so it may not prove effectiveness. Statins can cause muscle or liver side effects.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 9 people

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

Started

Jun 2026

Expected to finish

Sep 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

2 to 18 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: * KD complicated with CAA, less than 20 days after the onset of KD, or more than 20 days after onset but the KD inflammation has not been controled. * IVIG and/or other anti-inflammatory treatments have been used/are being used. * The guardians agree to atorvastatin treatment and sign the informed consent form. Exclusion Criteria: * Patients with history of family hypercholesterolemia/taking statins/severe chronic diseases. * Patients with abnormal laboratory data including CK≥500U/L, total cholesterol\<3.1mmol/L, ALT or AST≥ 2 times the upper limit of normal. * The guardians do not agree to atorvastatin treatment.

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Conditions

The condition(s) this trial relates to.

coronary artery congenital malformation Kawasaki disease

As listed by the trial registrant

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

Coronary artery abnormalities Kawasaki disease

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

  • Children's Hospital of Fudan University

    RECRUITING

    Shanghai, 201102, China

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