New stroke drug could give patients up to 24 hours to seek treatment
NCT ID NCT07201688
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 890 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Puyang Oilfield General Hospital
RECRUITINGPuyang, Henan, 457001, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can an implanted heart monitor catch hidden irregular heartbeats after stroke?
- China builds national watchdog for brain blood vessel devices
- Can tiny neural exosomes help the brain heal after a severe stroke?
- Can a new antibody boost recovery after severe stroke?
- After stroke, a balloon or a stent? trial tests which rescue opens blocked brain arteries better