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New hope for Wake-Up stroke patients: drug may boost recovery

NCT ID NCT07475949

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 352 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • 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.