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New cocktail aims to boost brain repair after stroke

NCT ID NCT07283159

Disease control Sponsor: General Hospital of Shenyang Military Region 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether adding a protein from human urine (human urinary kallidinogenase) to the standard clot-busting drug tenecteplase helps people recover better after an acute ischemic stroke. The trial will enroll 200 adults who arrive at the hospital within 4.5 hours of stroke onset. The goal is to see if the combination improves functional outcomes without raising the risk of bleeding.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Tenecteplase and human urinary kallidinogenase (a protein from human urine that may help blood flow and reduce inflammation)
What this could lead to
If it works, this combination could become a new standard treatment to improve neurological recovery after acute ischemic stroke without increasing bleeding risk.
What could go wrong
This is an early phase 2 trial with only 200 participants, so results may not apply to all stroke patients. The added benefit of the second drug is unproven, and there is always a risk of side effects like bleeding.

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 200 people

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

Started

Jan 2026

Expected to finish

Dec 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: * Age ≥ 18 year; * Acute ischemic stroke confirmed by neuroimaging; * The time from last known well to treatment is within 4.5 hours; * NIHSS ≥ 6 at randomization; * Received intravenous tenecteplase (0.25mg/kg); * First stroke onset or past stroke without obvious neurological deficit (mRS≤1); * Signed informed consent. Exclusion Criteria: * Planed for endovascular treatment; * Use of Edaravone Injection, Edaravone Dexborneol Injection, Butylphthalide Injection or Capsules after the onset of the current episode； * Prior use of ACE inhibitors within a period less than 5 half-lives before the intended administration of Urinary Kallidinogenase for Injection； * Pregnancy； * Allergy to the investigational drug(s)； * Comorbidity with other serious diseases; * Participating in other clinical trials within 3 months; * Patients not suitable for the study considered by researcher.

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Conditions

The condition(s) this trial relates to.

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

    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

  • Department of Neurology, General Hospital of Northern Theater Command

    RECRUITING

    Shenyang, 110016, China

More trials for these conditions

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