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Could anakinra save brain tissue after a stroke? new trial aims to find out

NCT ID NCT07423975

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether the drug anakinra can limit brain damage in people who have had a severe stroke and have already undergone a procedure to remove a blood clot. About 159 adults aged 18-80 will receive either standard care or anakinra at different doses. The main goal is to see if anakinra reduces the growth of the stroke-damaged area on brain scans.

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

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 159 people

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

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

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 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: * Age between 18-80 years old (both inclusive); * Acute ischemic stroke symptom onset within 24 hours; including wake-up stroke and unwitnessed stroke, onset time refers to "last-seen normal time"; * Pre-stroke modified Rankin scale (mRS) score ≤1; * Baseline National Institutes of Health Stroke Scale (NIHSS) 6-25 (both inclusive); * Internal carotid artery (ICA) or middle cerebral artery (MCA) M1/M2 occlusions confirmed by CTA/MRA and responsible for the signs and symptoms of acute ischemic stroke; * Successful recanalization (eTICI 2b50-3) after endovascular treatment; * Written informed consent from patients or their legally authorized representatives. Exclusion Criteria: * Allergy to Anakinra; * NIHSS consciousness score 1a \>2, or epileptic seizure, hemiplegia after seizures (Todd's palsy) or other neurological/mental illness such that the patient is not able to cooperate or unwilling to cooperate; * Unable to perform CTP or PWI; * Acute or past intracerebral hemorrhage (ICH) (including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/epidural hematoma) confirmed by CT or MRI; * Multiple arterial occlusion (e.g., bilateral MCA occlusion, MCA occlusion accompanied with basilar occlusion); * Glomerular filtration rate (GFR) \<30 mL/min or serum creatinine level \>2.5 mg/dL; * Suspected septic embolism or infective endocarditis; * Neutropenia (ANC \<1.5 × 109/L); * Known active or recurrent liver disease (including cirrhosis, hepatitis B and C; positive or indeterminate laboratory results), or alanine aminotransferase (ALT)/aspartate aminotransferase (AST) levels \>3 times the upper limit of normal (ULN) or total bilirubin \>2 times ULN; * History of malignancy other than basal cell carcinoma of the skin; * History or evidence of active or latent tuberculosis infection, or presence of tuberculosis risk factors including but not limited to: close contact with active tuberculosis patients within the past 12 months; * Any terminal illness such that the patient would not be expected to survive more than 1 year; * Pregnant women, nursing mothers, or reluctance to use effective contraceptive measures during the period of trial; * Unlikely to adhere to the trial protocol or follow-up; * Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study; * Participation in other interventional clinical trials within the previous 3 months.

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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

    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

  • Beijing tiantan hospital

    Beijing, Beijing Municipality, 100070, China

More trials for these conditions

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