Could a double-barrel cholesterol drug shrink artery plaque better than statins alone?

NCT ID NCT07036991

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 10, 2026 · Last updated Aug 07, 2026 · Updated 1 time

Summary

This study compares two approaches for people with mild-to-moderate carotid artery stenosis (narrowing of the neck arteries): a standard statin regimen versus a statin plus a PCSK9 inhibitor (evolocumab) given as biweekly injections. The main goal is to see whether the combination reduces plaque buildup more effectively over six months. Participants are adults who do not need surgery and have at least 30% plaque burden on ultrasound.

What this could mean

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

Active substance
Evolocumab (biweekly injections) plus rosuvastatin or atorvastatin, with or without ezetimibe
What this could lead to
If it works, this could point toward a more effective way to shrink artery plaque and lower stroke risk in people with carotid artery stenosis.
What could go wrong
This is an observational study, not a randomized trial, so results may be less definitive. The added drug also requires regular injections and may cause side effects 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 406 people

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

Started

Sep 2025

Expected to finish

Jun 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

For patients with mild to moderate carotid artery stenosis, those who are confirmed to meet the clinical inclusion and exclusion criteria and whose carotid artery plaque burden rate is confirmed to be ≥ 30% through carotid artery ultrasound examination can be registered.

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: Clinical inclusion criteria: 1. Age ≥ 18 years. 2. Asymptomatic mild-to-moderate carotid artery stenosis confirmed by CTA, MRA, ultrasound, or DSA, with no anticipated need for surgical intervention. 3. Modified Rankin Scale (mRS) score ≤ 2 4. Signed informed consent form obtained from the subject Ultrasound Inclusion Criteria: Carotid ultrasound showing a plaque burden rate ≥30% at the most stenotic cross-sectional site of the carotid artery (common carotid artery or proximal C1 segment of the internal carotid artery). Exclusion Criteria: 1. Non-atherosclerotic carotid stenosis, including arterial dissection, Takayasu arteritis, radiation-induced vasculopathy, fibromuscular dysplasia, neurofibromatosis, suspected vasospasm, or recanalized vascular embolism. 2. Known cardioembolic sources: mitral stenosis, mechanical heart valve, infective endocarditis, intracardiac thrombus/vegetation, myocardial infarction within 3 months, dilated cardiomyopathy, chronic/paroxysmal atrial fibrillation. (Confound ASCVD outcome assessment.) 3. History of cerebrovascular, coronary, or peripheral arterial endovascular intervention within 30 days before enrollment or anticipated surgery within the next 6 months. 4. History of ischemic stroke, transient ischemic attack (TIA), or intracranial hemorrhage (parenchymal, subarachnoid, subdural, or epidural) before enrollment. 5. Pre-existing intracranial tumor, cerebral aneurysm, or arteriovenous malformation. 6. History of thromboembolic diseases (pulmonary embolism, mesenteric embolism, lower limb arterial embolism) or coronary atherosclerotic heart disease. 7. Severe neurological deficits impairing independent living; diagnosed dementia/psychiatric disorders interfering with follow-up; or life expectancy \<3 years due to other conditions. 8. Severe/unstable comorbidities: Severe heart failure (NYHA Class III/IV or LVEF \<30%), Renal failure (serum creatinine \>264 μmol/L or creatinine clearance \<0.6 mL/s), Severe hepatic dysfunction (ALT/AST \>3× upper limit of normal), CK \>5× upper limit of normal, Active malignancy. 9. Use of PCSK9 inhibitors or CETP inhibitors within 24 weeks before enrollment. 10. The subjects have taken strong inhibitor drugs of cytochrome P-450 3A4 (including: adagrasib, atazanavir, ceritinib, clarithromycin, darunavir, idelalisib, indinavir, itraconazole, ketoconazole, levonorgestrel, lonafarnib, lopinavir, mifepristone, nefazodone, nelfinavir, nirmatrelvir/ritonavir, Viekira Pak (ombitasvir, paritaprevir, and ritonavir tablets), mbitasvir/paritaprevir/ritonavir and dasabuvir, posaconazole, co-formulations containing ritonavir and ritonavir itself, saquinavir, erythromycin, tucatinib, voriconazole) within one month before randomization, or may require such drugs during the study period. 11. Pregnancy or lactation. 12. Concurrent participation in another trial that may affect outcome assessment. 13. Other situations that the investigator believes may cause significant harm to the subjects if they participate in this trial. 14. Situations where the investigator believes there are other vascular lesions that may lead to short - term ischemic events and surgeries.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

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Contacts and locations

Locations

  • Changhai Hospital

    RECRUITING

    Shanghai, China

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