New hope for stroke patients: drug may work even after 4.5 hours
NCT ID NCT06994975
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a drug called tenecteplase can help people who have had a stroke and cannot get treatment within the usual 4.5-hour window. About 890 Chinese adults with a moderate to severe stroke will receive either the drug or standard care. Doctors will use a special CT scan to select patients who might still benefit from this clot-busting medicine.
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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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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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
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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. Suspected acute ischemic stroke of anterior cerebral circulation. 2. Last known well time \>4.5 hours. 3. Age ≥18 years old. 4. Baseline NIHSS (National Institutes of Health Stroke Scale) score \>5. 5. Premorbid modified Rankin Scale (mRS) ≤1. 6. Imaging criteria: Automated infarct segmentation by NCCT post-processing model indicates infarct core volume \<50 mL with no visible hypodensity in \>1/3 of the MCA territory. 7. Informed consent signed by the patient or the patient's legally authorized representative. Exclusion Criteria: 1. Obvious hypodensity on NCCT deemed related with the current stroke event, with no expected benefit from thrombolysis as assessed by the investigators 2. Endovascular thrombectomy (EVT) planned at the time of randomization 3. Allergy to the test drug and its ingredients 4. Rapidly improving symptoms at the discretion of the investigator 5. Any sign of an acute intracranial hemorrhage or subarachnoid hemorrhage identified on baseline NCCT 6. History of any intracranial hemorrhage 7. History of ischemic stroke or major head trauma within the last 3 months 8. History of intracranial/intraspinal surgery during the last 3 months 9. Gastrointestinal malignancy or gastrointestinal bleeding within 21 days 10. Known bleeding diatheses; platelets count \< 100000/mm3, international normalized ratio \> 1.7, prothrombin time \> 15 s, or activated partial thromboplastin clotting time \> 40 s 11. Treatment with a full dosage of low-molecular weighted heparin in the last 24 hours 12. Treatment with direct thrombin inhibitors or direct factor Xa inhibitors within the previous 48 hours unless the laboratory test of coagulation function is normal 13. Initial systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥100 mmHg 14. Initial glucose levels \<2.8 or 22.22 mmol/L 15. Known or suspected aortic arch dissection In addition to: 1. Clinical presentation or imaging profile consistent with Moyamoya disease/syndrome. 2. Pregnancy or breastfeeding. 3. Recent participation in another investigational drug or device study or registry in the past 30 days before enrollment. 4. Any terminal illness such that the patient would not be expected to survive more than three months. 5. Other conditions in which investigators believe that participating in this study may be harmful to the patient.
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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
2 sites. 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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Huashan Hospital
RECRUITINGShanghai, Shanghai Municipality, 200040, China
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Huashan Hospital, Fudan University
NOT_YET_RECRUITINGShanghai, 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