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New hope for mild stroke: Clot-Buster may help when time is lost

NCT ID NCT07476898

Disease control Sponsor: First Hospital of China Medical University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests whether a clot-dissolving drug called tenecteplase works better than standard antiplatelet pills for people who have a mild but disabling stroke caused by a large blocked artery. About 864 adults who arrive at the hospital 4.5 to 24 hours after symptoms start will be randomly assigned to receive either the drug or dual antiplatelet therapy. The main goal is to see if more patients recover with little or no disability 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 864 people

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

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Aug 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: * Male or female subjects (age ≥ 18 years). * Diagnosis of acute ischemic stroke, with intracranial hemorrhage ruled out by CT or MRI. * Time from stroke onset or last known well to randomization is 4.5 to 24 hours. * NIHSS score 2-5 and meeting the definition of disabling deficit: complete hemianopia (NIHSS question 3 score ≥ 2); severe aphasia (NIHSS question 9 score ≥ 2); neglect (NIHSS question 11 score ≥ 1); any persistent limb weakness against gravity (NIHSS question 6 or 7 score ≥ 2); any functional deficit considered potentially disabling by the physician and patient, such as inability to perform basic activities of daily living (bathing, independent walking, toileting, personal hygiene, and eating) or return to work. * LVO (internal carotid artery, middle cerebral artery M1/M2 segments) confirmed by CTA or MRA, including tandem lesions. * Core infarct volume \< 70 ml, ischemic penumbra volume ≥ 15 ml, and mismatch ratio ≥ 1.8, as shown by CTP or MRI+MRP. * Written informed consent. Exclusion Criteria: * Significant pre-stroke neurological deficit (pre-stroke mRS ≥ 2). * History of stroke within the last 3 months. * History of intracranial hemorrhage. * Suspected subarachnoid hemorrhage. * Intracranial tumor, vascular malformation, or aneurysm. * Major surgery within the last 1 month. * Systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg. * Platelet count \< 10⁵/mm³. * Heparin or oral anticoagulant therapy within 48 hours. * Abnormal APTT. * Thrombin or factor Xa inhibitors. * Severe illness with life expectancy \< 3 months. * Blood glucose \< 50 mg/dL (2.7 mmol/L). * Participation in any other investigational drug or device study within the last 3 months. * Pregnancy. * Patients deemed unsuitable for the registry study by the investigator.

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Conditions

The condition(s) this trial relates to.

ischemic stroke large artery stroke stroke disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Stroke

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    30 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

  • Anshan Central Hospital

    Anshan, Liaoning, 114001, China

  • Anshan Changda Hospital

    Anshan, Liaoning, 114005, China

  • Benxi Central Hospital

    Benxi, Liaoning, 117000, China

  • Central Hospital Affiliated to Shenyang Medical College

    Shenyang, Liaoning, 110024, China

  • Chaoyang Central Hospital

    Chaoyang, Liaoning, 122000, China

  • Dalian Municipal Central Hospital Affiliated of Dalian University of Technology

    Dalian, Liaoning, 116033, China

  • Dandong Central Hospital

    Dandong, Liaoning, 118000, China

  • Dandong First Hospital

    Dandong, Liaoning, 118000, China

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001, China

  • Fushun Central Hospital

    Fushun, Liaoning, 113006, China

  • Fuxin People's Hospital

    Fuxin, Liaoning, 123000, China

  • Huludao Central Hospital

    Huludao, Liaoning, 125000, China

  • Liaojian Group Fukuang General Hospital

    Fushun, Liaoning, 113008, China

  • Liaojian Group Tieling Coal General Hospital

    Tieling, Liaoning, 112700, China

  • Liaoning Provincial People's Hospital

    Shenyang, Liaoning, 110016, China

  • Liaoyang Central Hospital

    Liaoyang, Liaoning, 111000, China

  • Panjin Central Hospital

    Panjin, Liaoning, 124010, China

  • Shenyang Fifth People's Hospital

    Shenyang, Liaoning, 110023, China

  • Shenyang First People's Hospital

    Shenyang, Liaoning, 110041, China

  • Shenyang Fourth People's Hospital

    Shenyang, Liaoning, 110031, China

  • Shenyang Tenth People's Hospital

    Shenyang, Liaoning, 110044, China

  • Sujiatun District Central Hospital

    Shenyang, Liaoning, 110101, China

  • The First Affiliated Hospital of Jinzhou Medical University

    Jinzhou, Liaoning, 121001, China

  • The Fourth Affiliated Hospital of China Medical University

    Shenyang, Liaoning, 110032, China

  • The Second Affiliated Hospital of Shenyang Medical College

    Shenyang, Liaoning, 110002, China

  • Tieling Central Hospital

    Tieling, Liaoning, 112000, China

  • Tieling County Central Hospital

    Tieling, Liaoning, 112600, China

  • Wafangdian Central Hospital

    Wafangdian, Liaoning, 116300, China

  • Wafangdian Third People's Hospital

    Wafangdian, Liaoning, 116300, China

  • Yingkou Central Hospital

    Yingkou, Liaoning, 115000, China

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