New hope for Wake-Up stroke patients: drug may boost recovery
NCT ID NCT07475949
First seen Jun 27, 2026 · Last updated Sep 01, 2026 · Updated 2 times
Summary
This study tests a medicine called tenecteplase for people who have a stroke but don't know exactly when it started, like waking up with symptoms. About 352 adults will get either tenecteplase or standard care after a simple CT scan. The goal is to see if the drug helps them recover better after 90 days.
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 352 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 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 old. 2. Clinical diagnosis of acute ischemic stroke. 3. Unknown time of stroke onset (e.g., stroke symptom recognized on awakening) but last-known normal time \>4.5 hours. 4. Time from stroke symptom recognition (e.g., awakening) to randomization within 3 hours. 5. National Institutes of Health Stroke Scale (NIHSS) score of 6-25 (both inclusive). 6. Pre-stroke modified Rankin Scale (mRS) score of 0-1. 7. Written informed consent from patients or their legally authorized representatives. Exclusion Criteria: 1. Intracranial hemorrhage confirmed by skull CT, or history of intracranial hemorrhage. 2. Planned endovascular treatment. 3. Rapid neurological improvement with NIHSS \<6 at randomization. 4. Allergy to tenecteplase. 5. Use of vitamin K antagonist with INR \>1.7, use of heparin or low molecular heparin in the past 24 hours, or use of direct oral anticoagulants in the past 48 hours. 6. Hypodensity on non-contrast CT \>1/3 middle cerebral artery territory. 7. Severe traumatic brain injury or other major trauma in the past 3 months. 8. Intracranial neoplasm, arteriovenous malformation, or aneurysm (≥10mm). 9. Intracranial surgery, intraspinal surgery, or other major surgery in the past 3 months. 10. Gastrointestinal or urinary tract hemorrhage in the past 3 weeks. 11. Active internal bleeding. 12. Aortic dissection. 13. Infective endocarditis. 14. Platelet count \<100×10\^9/L. 15. Women who are pregnant or breastfeeding. 16. Blood glucose \<50 or \>400 mg/dL (\<2.78 or \>22.2 mmol/L). 17. Systolic blood presure \>185 mmHg or diastolic blood presure \>110 mmHg refractory to treatment. 18. Life expectancy \<3 months. 19. Participating in other trials. 20. Any condition that, in the judgment of the investigator, makes the patient unsuitable for this study or where this study may impose a significant risk to the patient (e.g., inability to understand and/or comply with study procedures and/or follow-up due to psychiatric disorders, cognitive or emotional impairment).
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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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The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021, 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