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Could a single shot boost stroke recovery? new trial aims to find out

NCT ID NCT07466251

Disease control Sponsor: Peking Union Medical College Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jul 16, 2026 · Updated 4 times

Summary

This study tests whether a single injection of Recaticimab, a cholesterol-lowering drug, can help people recover better after a stroke caused by narrowed brain arteries. About 1,200 participants will receive either the drug or a placebo, plus standard care. The main goal is to see if more people achieve a good functional outcome (able to look after themselves) 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
Recaticimab (a PCSK9 inhibitor, a type of cholesterol-lowering drug)
What this could lead to
If it works, this could provide a new treatment option to improve recovery after a stroke caused by plaque buildup in brain arteries.
What could go wrong
This is a phase 4 trial, but it hasn't started yet. The drug may not improve outcomes more than standard therapy, and there are always risks with any medication.

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 1,212 people

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

Expected to start

Sep 2026

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

30 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. Age 30 to 80 years, inclusive. 2. Acute ischemic stroke with symptom onset within 72 hours before screening, diagnosed on the basis of neurological deficits and CT or MRI findings. 3. National Institutes of Health Stroke Scale (NIHSS) score of 4 to 25 at hospital admission. 4. CTA, DSA, or MRA evidence that the culprit intracranial artery has atherosclerotic stenosis of 50% to 99%. Exclusion Criteria 1. Intracranial arterial stenosis attributable to a nonatherosclerotic cause, such as arterial dissection, moyamoya disease, or systemic vasculitis. 2. Any definite source of cardioembolism, such as atrial fibrillation, a mechanical prosthetic heart valve, left ventricular thrombus, or patent foramen ovale. 3. Clinical and imaging findings suggesting that the index ischemic event is primarily attributable to cerebral small vessel disease. 4. Pre-stroke disability, defined as a modified Rankin Scale score of 2 or higher before the index ischemic event. 5. Extensive cerebral infarction on CT or MRI, such as an Alberta Stroke Program Early CT Score (ASPECTS) below 6 or an infarct volume of 70 mL or greater. 6. Previous stent implantation in the culprit vessel or planned stent implantation in the culprit vessel within 3 months after enrollment. 7. Any intracranial hemorrhage within 3 months before enrollment. 8. An intracranial tumor; or a cerebral aneurysm or arteriovenous malformation judged to require interventional treatment. 9. Severe active bleeding tendency or coagulation disorder. 10. Severe cardiac, hepatic, renal, or other major organ dysfunction. 11. Treatment with a PCSK9 monoclonal antibody inhibitor within 1 month before enrollment or with a PCSK9-targeting small interfering RNA therapy within 6 months before enrollment. 12. A definite contraindication to statin therapy or a history of statin intolerance. 13. Pregnant or breastfeeding, or planning to become pregnant during the study. 14. Current participation in another clinical trial.

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Conditions

The condition(s) this trial relates to.

intracranial arteriosclerosis ischemic stroke Plaque, Atherosclerotic

As listed by the trial registrant

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

Acute ischemic stroke (AIS) Atherosclerotic plaque Intracranial atherosclerosis icas

How to take part

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

  1. The places running it

    19 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

  • Affiliated Taihe Hospital of Hubei University of Medicine

    Shiyan, Hubei, China

  • Baotou Central Hospital

    Baotou, Inner Mongolia, 014000, China

  • Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine

    Cangzhou, Hebei, China

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100853, China

  • Chongqing General Hospital

    Chongqing, China

  • First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, China

  • Hebei Provincial People's Hospital

    Shijiazhuang, Hebei, 050051, China

  • Huashan Hospital, Fudan University

    Shanghai, China

  • Jining First People's Hospital

    Jining, Shandong, 272000, China

  • Liaocheng People's Hospital

    Liaocheng, Shandong, 252000, China

  • Nanjing First Hospital

    Nanjing, Jiangsu, 210000, China

  • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, Beijing 100730

    Beijing, China

  • Peking University Third Hospital Qinhuangdao Hospital

    Qinhuangdao, Hebei, China

  • Tangshan Worker's Hospital

    Tangshan, Hebei, 063000, China

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, China

  • The Third Affiliated Hospital of Sun Yat-sen University, Yuedong Hospital

    Meizhou, Guangdong, China

  • The first affiliated hospital of zhengzhou university

    Zhengzhou, Henan, China

  • Weifang People's Hospital

    Weifang, Shandong, 261000, China

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei, China

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