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New hope for stroke patients: drug may work even after 4.5 hours

NCT ID NCT06994975

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

Phase 3

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

Participants

About 890 people

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

Started

Nov 2025

Expected to finish

Jun 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. 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.

  1. The places running it

    2 sites. 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

  • Huashan Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 200040, China

  • Huashan Hospital, Fudan University

    NOT_YET_RECRUITING

    Shanghai, China

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