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Can powerful cholesterol drugs remodel dangerous artery plaques?

NCT ID NCT07819643

Disease control Sponsor: Keqiang Zhao 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 15, 2026 · Last updated Sep 16, 2026 · Updated 1 time

Summary

Researchers are testing whether adding a PCSK9 inhibitor to standard statin therapy can stabilize vulnerable plaques in the carotid artery, the main blood vessel to the brain. The trial enrolls 120 adults with carotid narrowing and high-risk plaque features. Participants receive either a statin alone or a statin plus a PCSK9 inhibitor injection. High-resolution MRI scans track changes in plaque composition over 24 months.

What this could mean

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

Active substance
PCSK9 inhibitors (evolocumab or alirocumab) added to statin therapy
What this could lead to
If it works, this could offer a way to stabilize dangerous carotid plaques and lower stroke risk beyond what statins alone achieve.
What could go wrong
The trial is small and single-center, and it measures plaque changes on imaging rather than stroke outcomes. Plaque remodeling may not translate into fewer strokes, and injectable PCSK9 inhibitors carry costs and 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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 120 people

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

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Dec 2029

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

40 to 80 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: 1. . Carotid stenosis ≥30% detected by carotid ultrasound, not meeting criteria for surgical intervention, and confirmed presence of vulnerable plaque by HR-MRI (meeting any of the following: incomplete or thin fibrous cap \<0.5 mm; lipid-rich necrotic core \[LRNC\] volume ≥40% of plaque volume; intraplaque hemorrhage \[IPH\]; or neovascularization). 2. Receiving standard statin therapy (moderate intensity or higher) for ≥3 months, with LDL-C still ≥1.8 mmol/L (70 mg/dL). 3. Willing to adhere to follow-up and provide signed informed consent. Exclusion Criteria: 1. Allergy or contraindication to PCSK9 inhibitors. 2. Active liver disease, myopathy, or creatine kinase (CK) elevation \>5 times the upper limit of normal. 3. History of carotid revascularization (carotid endarterectomy \[CEA\] or carotid artery stenting \[CAS\]). 4. Renal insufficiency (estimated glomerular filtration rate \[eGFR\] \<30 ml/min). 5. MRI contraindications such as metallic implants or claustrophobia. 6. Life expectancy \<3 years.

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Conditions

The condition(s) this trial relates to.

carotid stenosis cerebral atherosclerosis intracranial arteriosclerosis

As listed by the trial registrant

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

Atherosclerosis cerebral Carotid plaque Carotid stenosis Vulnerable plaque

How to take part

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  1. The official record

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