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New drug combo may slash heart attacks in high-risk patients

NCT ID NCT06863545

Disease control Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests whether adding a powerful cholesterol-lowering drug (PCSK9 inhibitor) to standard treatment can prevent heart attacks, strokes, and death in people with high-risk coronary plaques seen on CT scans. About 3,600 adults with at least one severely narrowed or high-risk plaque will be followed to compare outcomes. The goal is to see if the extra medication offers better protection than standard therapy alone.

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 3,596 people

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

Started

Apr 2025

Expected to finish

Apr 2033

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

18 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. Subject must be ≥ 18 years. 2. Patients with at least one target lesion meet CCTA-detected plaque features of the following: 1. Degree of stenosis ≥ 50% or plaque burden ≥ 70% 2. At least 2 of the following high-risk plaque features: i. Low-attenuation plaque ii. Positive remodeling iii. Napkin-ring sign iv. Spotty calcium 3. The target lesion is located at the proximal or mid segment of left anterior descending artery, left circumflex artery or right coronary artery. 4. Subject is able to confirm his/her understanding of the risks, benefits, and treatment alternatives of receiving study-related treatment. He/she or his/her legally authorized representative provides written informed consent prior to any study-related procedure. Exclusion Criteria: 1. Target lesions underwent or planned to revascularization. 2. Patients with acute coronary syndrome. 3. New York Heart Association class III or IV, or last known left ventricular ejection fraction \< 30%. 4. Uncontrolled or recurrent ventricular tachycardia. 5. Homozygous familial hypercholesterolemia. 6. Active liver disease or hepatic dysfunction. 7. Failed CCTA plaque analysis. 8. Non-cardiac co-morbid conditions with life expectancy \< 2 years. 9. Pregnant and/or lactating women. 10. Known hypersensitivity or contraindication to statin or PCSK9 inhibitors.

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Conditions

The condition(s) this trial relates to.

coronary artery disorder

As listed by the trial registrant

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

Cardiovascular events Coronary artery disease CT angiography PCSK9

How to take part

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

  1. The places running it

    6 sites in 2 countries. 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

  • Hangzhou Linping First People's Hospital

    RECRUITING

    Hangzhou, China

  • Jinhua Central Hospital

    RECRUITING

    Jinhua, China

  • Seoul National University Hospital

    NOT_YET_RECRUITING

    Seoul, South Korea

  • The Second Affiliated Hospital, School of Medicine, Zhejiang University

    RECRUITING

    Hangzhou, China

  • Zhejiang Hospital

    RECRUITING

    Hangzhou, China

  • Zhejiang Provincial Hospital of Traditional Chinese Medicine

    RECRUITING

    Hangzhou, Zhejiang, China

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