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Can a quick cholesterol shot boost stroke recovery?

NCT ID NCT07002476

Disease control Sponsor: Shanghai East Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 03, 2026 · Updated 2 times

Summary

This study tests whether giving a strong cholesterol-lowering drug (PCSK9 inhibitor) before emergency stroke treatment helps people recover better. About 652 adults with a major stroke will be randomly assigned to receive either the intensive drug or standard care. The main goal is to see if more people are independent and disability-free 90 days after their stroke.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 978 people

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

Started

Jun 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.

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: * Adults (age 18 years and older); * Imaging diagnosis of acute ischemic stroke with anterior circulation large vessel occlusion (including: internal carotid artery, middle cerebral artery M1 and M2, anterior cerebral artery A1 and A2); * Planned to undergo endovascular intervention within 24 hours of symptom onset (or last known well time) according to local guidelines; * Provision of informed consent by the patient or his/her legally authorized representative (or by an appropriate agent according to local requirements). Exclusion Criteria: * ASPECTS score ≤5 on cranial CT imaging; * Pre-existing functional impairment, with mRS score \>2; * Patients who are allergic to PCSK9 inhibitors; * Patients who have received PCSK9 monoclonal antibody within 1 month prior to enrollment or PCSK9 siRNA therapy within 6 months prior to enrollment; * Severe renal insufficiency, defined as estimated glomerular filtration rate (eGFR) \< 15 mL/min/1.73m2 at final screening; * Active liver disease or hepatic dysfunction, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3 times the upper limit of normal; * Severe, concomitant non-cardiovascular disease expected to reduce life expectancy to less than 3 months; * Pregnant or lactating women; * Patients who are participating in other clinical trials; * Other conditions deemed unsuitable for inclusion in the clinical study by the investigator.

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Conditions

The condition(s) this trial relates to.

Ischemic Stroke large artery stroke stroke disorder

As listed by the trial registrant

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

Stroke

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

    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

  • Shanghai East Hospital, Tongji University

    RECRUITING

    Shanghai, 200127, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.