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New combo therapy shows promise in preventing stroke worsening

NCT ID NCT06696820

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Updated 1 time

Summary

This study tested whether giving a powerful cholesterol-lowering drug (evolocumab) along with standard statins within 48 hours of a stroke could prevent early neurological decline. It included 429 adults with moderate to severe narrowing of brain arteries. The goal was to see if the combo reduces worsening of symptoms and improves recovery over 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
Evolocumab (a PCSK9 inhibitor) combined with atorvastatin or rosuvastatin
What this could lead to
If successful, this combination could become a standard early treatment to prevent neurological worsening after a stroke caused by narrowed brain arteries.
What could go wrong
This is a Phase 2/3 trial with 429 participants, so results are still preliminary. The open-label design may introduce bias, and there is a risk of bleeding or other side effects from the drug combination.

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

429 people

The number who actually took part.

Started

Nov 2024

Finished

Jun 2026

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: 1. Age ≥ 18 years. 2. Acute ischemic stroke diagnosed by CT or MRI of the head. 3. Symptom onset to randomization within 48 hours, including wake-up strokes or strokes without a witnessed onset. The time of symptom onset is defined as the "last known normal time." 4. NIHSS score ≤ 20. 5. mRS score of 0-1 prior to the current stroke. 6. Moderate or severe intracranial stenosis or occlusion (≥50%) confirmed by CTA, MRA, or DSA, involving the responsible intracranial arteries: intradural internal carotid artery, M1-2 segments of the middle cerebral artery, A1 segment of the anterior cerebral artery, V4 segment of the vertebral artery, basilar artery, or P1 segment of the posterior cerebral artery. 7. The participant or legal representative has signed the informed consent form. Exclusion Criteria: 1. Cardiogenic embolism (e.g., atrial fibrillation, cardiac valvular disease, etc.). 2. Symptomatic intracranial stenosis or occlusion due to arteritis, arterial dissection, moyamoya disease, or other similar conditions. 3. Patients who have received intravenous thrombolysis or mechanical thrombectomy. 4. Use of PCSK9 inhibitors within the 1 month prior to the onset of the stroke. 5. Allergy to statins or PCSK9 inhibitors. 6. Active liver disease, including unexplained persistent elevations of alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST). 7. Known severe renal impairment (creatinine clearance \<30 mL/min). 8. Myopathy. 9. Concurrent use of cyclosporine. 10. Known pregnancy or breastfeeding, or a positive pregnancy test prior to randomization. 11. Life expectancy \<3 months (e.g., due to severe cardiopulmonary disease, renal failure, malignancy, or other terminal conditions). 12. Participation in other interventional clinical trials that may impact outcome assessments. 13. Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation or poses significant risks to the patient.

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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.

Contacts and locations

Locations

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430030, China

  • Tongji Hospital,Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430030, China

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