New hope for stroke patients: drug may work up to 24 hours later
NCT ID NCT07606807
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a drug called tenecteplase (TNK) for people who have had a stroke caused by a blood clot in the brain. The drug is given up to 24 hours after symptoms start, using only a simple CT scan to decide who can get it. The goal is to see if TNK helps people recover better than standard care. The study will include 750 adults with moderate to severe stroke symptoms.
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 750 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 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. Age 18 years or older. 2. Presumed acute ischemic stroke of the anterior circulation. 3. Acute ischemic stroke symptom onset between 4.5 to 24 hours prior to enrollment; including wake-up stroke and unwitnessed stroke, onset time refers to 'last-known well time'. 4. Baseline National Institutes of Health Stroke Scale (NIHSS) 6-25 (inclusive). 5. Limited early ischemic changes on non-contrast CT (NCCT). 6. Written informed consent signed by patients or their legally authorized representatives. Exclusion Criteria: 1. Clearly demarcated hypodensity on non-contrast CT related to the current stroke, with limited anticipated clinical benefit as judged by the investigator. 2. Intracranial or subarachnoid hemorrhage identified on baseline NCCT. 3. Endovascular thrombectomy (EVT) planned at the time of randomization. 4. Pre-stroke mRS≥2. 5. Allergy to the test drug and its ingredients. 6. Severe head trauma or ischemic stroke in the last 3 months. 7. Intracranial or intraspinal surgery within 3 months before enrollment. 8. Intracranial tumor or large-size aneurysm found before enrollment. 9. Gastrointestinal or urinary system hemorrhage within the past 3 weeks. 10. Active visceral bleeding. 11. Aortic arch dissection confirmed by examination or medical history. 12. Infective endocarditis confirmed by examination or medical history. 13. Platelet count less than 100 × 109 /L. 14. Patients received heparin or low-molecular-weighted heparin treatment within 24h before enrollment. 15. Pregnant or lactating women. 16. Blood glucose \<50 mg/dl (2.78mmol/L) or \>400 mg/dl (22.2mmol/L) during screening. 17. Uncontrolled hypertension with persistent systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg, refractory to medical management. 18. Life expectancy less than 6 months due to malignancy, severe cardiopulmonary disease, or other terminal illness. 19. Participating in other trials. 20. Other conditions deemed unsuitable for the study by the investigator, such as inability to comprehend or comply with study procedures or follow-up due to mental illness, cognitive or emotional disorder.
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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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Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
RECRUITINGGuangzhou, 510120, 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