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New stroke drug could give patients up to 24 hours to seek treatment

NCT ID NCT07201688

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tests a drug called rhTNK-tPA (Mingfule) in people with acute ischemic stroke who can be treated 4.5 to 24 hours after symptoms start. The study plans to enroll 890 participants and will compare the drug to a placebo. The goal is to see if the drug helps patients recover better, as measured by their ability to perform daily activities independently.

What this could mean

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

Active substance
rhTNK-tPA (a clot-busting drug)
What this could lead to
If successful, this could allow more stroke patients to receive clot-busting treatment up to 24 hours after symptoms start, potentially reducing disability.
What could go wrong
This is an early Phase 3 trial, so results are not yet proven. There is a risk of bleeding in the brain, a known side effect of clot-busters.

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 890 people

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

Started

Nov 2025

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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. Aged ≥ 18 years, regardless of gender; 2. Time from symptom onset to treatment is 4.5 - 24 hours(Including the boundary values.), including patients with wake-up stroke or stroke without witnesses; the time of symptom onset is defined as the "last known normal time"; 3. Modified Rankin Scale (mRS) score ≤ 1 before stroke onset; 4. Baseline National Institutes of Health Stroke Scale (NIHSS) score ≥ 6; 5. Neuroimaging findings: occlusion of the internal carotid artery (ICA), M1 or M2 segment of the middle cerebral artery (MCA) confirmed by computed tomography angiography (CTA)/magnetic resonance angiography (MRA), which is the responsible vessel for the signs and symptoms of acute ischemic stroke; presence of target mismatch on computed tomography perfusion (CTP) or magnetic resonance imaging (MRI) + magnetic resonance perfusion (MRP) (ischemic core volume \< 70 mL, mismatch ratio ≥ 1.8, mismatch volume ≥ 15 mL); 6. Voluntary signing of the informed consent form by the participant or their legal guardian. Exclusion Criteria: 1. Patients with known allergy to recombinant human tissue plasminogen activator (rhTNK-tPA); 2. Patients with an expected life expectancy of less than 1 year; 3. Patients with rapidly improving symptoms (which may indicate spontaneous recanalization), as determined by the investigator; 4. Patients with a score of \> 2 on Item 1a (Level of Consciousness) of the National Institutes of Health Stroke Scale (NIHSS), or those who had a seizure at stroke onset, or had hemiplegia after seizure, or had other neurological/psychiatric disorders that rendered them unable or unwilling to cooperate; 5. Severe and persistent hypertension uncontrolled by medication ; 6. Blood glucose \< 2.8 mmol/L or \> 22.2 mmol/L; 7. Active internal bleeding with a high risk of hemorrhage; 8. Any known coagulation disorder; 9. Known platelet function defect or platelet count less than 100×10⁹/L;

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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

  • Puyang Oilfield General Hospital

    RECRUITING

    Puyang, Henan, 457001, China

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