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Stroke drug trial hopes to reduce disability with Anti-Inflammatory

NCT ID NCT07509645

Disease control Sponsor: Capital Medical University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 09, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether adding tocilizumab, an anti-inflammatory drug, to standard emergency stroke treatment improves outcomes for people with a severe stroke in the back of the brain. About 348 adults will receive either tocilizumab or a placebo by IV right before a procedure to reopen blocked arteries. The main goal is to see if more people can function 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
Tocilizumab (a drug that blocks interleukin-6, a protein involved in inflammation)
What this could lead to
If it works, this could lead to a new treatment that reduces disability after a severe stroke in the back of the brain.
What could go wrong
This is a mid-stage trial with 348 people, so results may not apply to all stroke patients. Tocilizumab can increase infection risk, and the benefit over standard care is unproven.

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 348 people

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

Started

Apr 2026

Expected to finish

Apr 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: 1. Age 18 years or older, of either sex; 2. Acute ischemic stroke caused by occlusion of the basilar artery; 3. Decide to undergo emergency endovascular treatment; 4. Time from stroke onset to groin puncture within 24 hours; 5. National Institutes of Health Stroke Scale (NIHSS) ≥ 10; 6. Posterior circulation Alberta Stroke Program Early computed tomography score (pc-ASPECTS) ≥ 6; 7. Signed informed consent from the patients or the legally authorized representatives. Exclusion Criteria: 1. Intracerebral hemorrhage, epidural hematoma, subdural hematoma, intraventricular hemorrhage, or subarachnoid hemorrhage; 2. Pre-stroke modified Rankin scale (mRS) score \>1; 3. Known allergy to tocilizumab or excipients; 4. Known allergy to iodinated contrast agents; 5. Anticipated difficulty in completing endovascular treatment due to vascular tortuosity; 6. History of congenital or acquired bleeding disorders, coagulation factor deficiency diseases, or thrombocytopenic diseases; 7. Systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg despite blood pressure control; 8. Neutrophils \< 2 × 10\^9 /L; 9. Platelets \< 100 × 10\^9 /L; 10. Blood glucose \<2.8 mmol/L (50 mg/dL) or \>22.2 mmol/L (400 mg/dL); 11. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels \>2 times the upper limit of normal; 12. Known recent or current serum creatinine \>2 times the upper limit of normal or estimated glomerular filtration rate (eGFR) \<60 mL/min; 13. Pregnant, lactating, or planning pregnancy within 90 days; 14. Severe mental disorders or inability to comply with informed consent and follow-up requirements due to dementia; 15. Concurrent malignant tumors or severe systemic diseases with expected survival of less than 90 days; 16. Presence of autoimmune diseases or use of immunosuppressive drugs; 17. Systemic infectious diseases; 18. Participation in another interventional clinical study within 30 days before randomization or currently participating in another interventional clinical study; 19. Any circumstance that, as assessed by the investigators, might result in harm to the patients if study therapy is initiated; 20. Other conditions that the investigator considers might affect compliance or preclude participation in this study.

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Conditions

The condition(s) this trial relates to.

basilar artery occlusion ischemic stroke

As listed by the trial registrant

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

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

    13 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

  • Anyang People's Hospital

    RECRUITING

    Anyang, Henan, 455000, China

  • Capital Medical Univercity Xuanwu Hospital

    RECRUITING

    Beijing, 100053, China

  • Lishui Central Hospital

    RECRUITING

    Lishui, Zhejiang, 323000, China

  • Nanyang Central Hospital

    RECRUITING

    Nanyang, Henan, 473000, China

  • People's Hospital of Linyi

    RECRUITING

    Linyi, Shandong, 276000, China

  • People's Hospital of Xihua

    RECRUITING

    Zhoukou, Henan, 466600, China

  • People's Hospital of Yueqing

    RECRUITING

    Yueqing, Zhejiang, 325600, China

  • Suzhou Municipal Hospital

    RECRUITING

    Suzhou, Anhui, 234000, China

  • Taizhou enze Hospital

    RECRUITING

    Taizhou, Zhejiang, 318000, China

  • The First Affiliated Hospital of Henan Medical University

    RECRUITING

    Xinxiang, Henan, 453000, China

  • Xianyang First People's Hospital

    RECRUITING

    Xianyang, Shanxi, 712000, China

  • Yuncheng Central Hospital

    RECRUITING

    Yuncheng, Shanxi, 044000, China

  • Zibo Central Hospital

    RECRUITING

    Zibo, Shandong, 255000, China

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