New Clot-Buster may be safer for stroke patients
NCT ID NCT07519889
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study will compare the safety of two clot-dissolving drugs, rhTNK-tPA and rt-PA, in 4500 adults having an acute ischemic stroke. Researchers will track how often each drug causes serious bleeding in the brain within 36 hours. The goal is to see if the newer drug, rhTNK-tPA, is safer in real-world use.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- clot-busting drugs (rhTNK-tPA and rt-PA)
- What this could lead to
- If rhTNK-tPA proves safer than rt-PA, it could become a preferred treatment for acute ischemic stroke, reducing the risk of brain bleeding.
- What could go wrong
- This is an observational study, not a randomized trial, so results may be influenced by patient differences. Both drugs carry a risk of serious bleeding in the brain.
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.
- Participants
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About 4,500 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 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.
Who is studied
The study population consists of adult patients diagnosed with acute ischemic stroke (AIS) who present to the emergency departments or stroke centers of participating hospitals in China. This cohort includes individuals who are eligible for intravenous thrombolysis (IVT) within the standard therapeutic time window and are treated with rhTNK-tPA or rt-PA in a real-world clinical setting.
- 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. Adult patients aged 18 years or older. 2. Time from symptom onset to treatment \< 4.5 hours, with the time of symptom onset defined as "last known normal time". 3. Meet the diagnostic criteria for acute ischemic stroke, confirmed by imaging (head CT or MRI). 4. Baseline National Institutes of Health Stroke Scale (NIHSS) score ≤ 25 points at admission. 5. Planned to receive intravenous thrombolysis with either rhTNK-tPA (Mingfule®) 0.25 mg/kg or rt-PA (Actilyse®) 0.9 mg/kg. 6. Voluntary signing of the informed consent form by the participant or their legal guardian. 7. Have complete clinical and imaging data, and be able to cooperate with follow-up assessments. Exclusion Criteria: 1. Patients with absolute contraindications to reperfusion therapy (including intravenous thrombolysis and mechanical thrombectomy), specifically: Intracranial hemorrhage (including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/epidural hematoma, etc.) History of prior intracranial hemorrhage Severe head trauma or stroke within the past 3 months Intracranial tumor or giant intracranial aneurysm Intracranial or intraspinal surgery within the past 3 months Major surgical procedure within the past 2 weeks Gastrointestinal or urinary tract bleeding within the past 3 weeks Active visceral bleeding Aortic arch dissection Arterial puncture at a non-compressible site within the past 1 week 11 Elevated blood pressure: systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 100 mmHg 12 Acute bleeding diathesis, including platelet count \< 100×10⁹/L or other conditions 13 Treatment with low molecular weight heparin within the past 24 hours 14 Oral anticoagulant use (warfarin) with INR \> 1.7 or PT \> 15 seconds 15 Use of thrombin inhibitors or factor Xa inhibitors within the past 48 hours, or abnormal laboratory tests deemed by the investigator to contraindicate thrombolysis (e.g., APTT, INR, platelet count, ECT, TT, or factor Xa activity assay) 16 Random blood glucose \< 2.8 mmol/L or \> 22.22 mmol/L 17 Head CT or MRI showing large-area infarction (infarct volume \> 1/3 of the middle cerebral artery territory) 2. Known pregnant or lactating female patients (judged by the investigator based on last menstrual period, medical history, or patient/family report). 3. Patients who have received prior reperfusion therapy outside the hospital (including intravenous thrombolysis and endovascular treatment). 4. Patients expected to be unable to complete follow-up (e.g., predicted survival \< 3 months, or inability to comply with follow-up plans for other reasons). 5. Patients participating in other clinical trials where the interventions may affect the results of this study.
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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 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.
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?
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- Can tiny neural exosomes help the brain heal after a severe stroke?