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Could a cholesterol drug boost stroke recovery?

NCT ID NCT07174375

Disease control Sponsor: Nanfang Hospital, Southern Medical University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests whether adding a PCSK9 inhibitor (a cholesterol-lowering drug) to standard care helps people recover better after a stroke caused by a blocked artery. About 478 adults who had a stroke and received a procedure to reopen the blocked vessel will be randomly assigned to get the drug or not. The main goal is to see if more people achieve a good functional outcome (able to live independently) at 90 days.

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)
What this could lead to
If successful, this could show that adding a cholesterol-lowering drug after stroke treatment improves recovery and reduces the chance of another stroke.
What could go wrong
This is an early-to-mid stage trial, so results may not be conclusive. The drug may not provide additional benefit over standard care, and there are risks like injection site reactions or muscle pain.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 478 people

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

Expected to start

Sep 2025

An estimate. Start dates often move.

Expected to finish

Dec 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

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: * Age ≥ 18 years. * Meets the diagnostic criteria for acute ischemic stroke according to the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2023. * Severe stenosis or occlusion of large anterior circulation vessels confirmed by DSA, MRA, or CTA. * Preoperative NIHSS score ≥ 4 and \< 25. * Meets the indications for endovascular therapy per the Chinese Guidelines for Endovascular Therapy of Acute Ischemic Stroke 2023, and successful reperfusion of the target vessel (mTICI ≥ 2b) achieved via emergency endovascular intervention. * LDL-C \> 1.8 mmol/L or non-HDL cholesterol \> 2.6 mmol/L. * Signed informed consent provided by the patient or their legally authorized representative. Exclusion Criteria: * Confirmed non-atherosclerotic causes of vascular stenosis/occlusion (e.g., cardioembolism, vasculitis, vascular malformation, moyamoya disease, iatrogenic causes). * History of intracranial hemorrhage or systemic bleeding within the past 3 months. * Presence of hemorrhagic transformation (PH1/PH2) immediately after the procedure. * Severe hepatic impairment: ALT \> 3 times the upper limit of normal, INR \> 1.2, hepatic encephalopathy, or history of drug-induced liver injury. * Use of PCSK9 inhibitors within 6 months prior to enrollment. * Pre-stroke mRS ≥ 2. * Terminal illness (e.g., malignancy, end-stage renal disease) with an expected survival of \< 3 months. * Pregnancy or lactation. * Other neurological diseases that may interfere with neurological function assessment during follow-up. * Allergy or intolerance to PCSK9 inhibitors or statins. * Participation in another interventional clinical trial.

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Conditions

The condition(s) this trial relates to.

ischemic stroke

As listed by the trial registrant

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

Acute ischemic stroke

How to take part

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

  1. The places running it

    12 sites. 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

  • Dongguan Donghua Hospital

    Dongguan, Guangdong, China

  • Dongguan People's Hospital

    Dongguan, Guangdong, China

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, China

  • Ganzhou City People's Hospital

    Ganzhou, Jiangxi, China

  • Haikou People's Hospital

    Haikou, Hainan, China

  • Hainan Provincial Hospital of Traditional Chinese Medicine

    Haikou, Hainan, 570100, China

  • Hainan Provincial People's Hospital

    Haikou, Hainan, China

  • Hengzhou City People's Hospital, Guangxi

    Hengzhou, Guangxi (Autonomous Region), China

  • Heyuan People's Hospital

    Heyuan, Guangdong, China

  • Huadu District People's Hospital of Guangzhou

    Guangzhou, Guangdong, China

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong, China

  • The Second Affiliated Hospital of Hainan Medical University

    Haikou, Hainan, China

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