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Could adding Clot-Busting drugs before surgery boost stroke recovery?

NCT ID NCT07748039

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time

Summary

This phase 3 trial is testing whether giving a clot-busting drug before mechanical thrombectomy (a procedure to physically remove a blood clot) improves outcomes for people with severe strokes caused by large vessel occlusion. Participants are randomly assigned to receive tenecteplase, reteplase, or no clot-busting drug before the procedure. The main goal is to see if more people achieve functional independence at 90 days after treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Tenecteplase or reteplase (clot-busting drugs) given before mechanical thrombectomy
What this could lead to
If successful, this could establish the best approach to treating severe strokes, potentially improving recovery and reducing disability for many patients.
What could go wrong
The trial is large but still experimental; the drugs may not improve outcomes over direct clot removal and carry a risk of bleeding.

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 1,440 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Aug 2029

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. Patients with acute ischemic stroke presenting within 4.5 hours of symptom onset who are eligible for intravenous thrombolytic therapy. A baseline non-contrast CT or MRI is required for screening. 2. Large vessel occlusion on computed tomographic angiography (CTA) or magnetic resonance angiography (MRA) of the intracranial carotid artery (ICA) or middle cerebral artery (MCA) M1 3. Age ⩾ 18 years at the time of signing the informed consent form 4. ASPECTS 6-10 5. Informed consent from the patients or their legal representative. Exclusion Criteria: 1. Intracranial hemorrhage (ICH) identified by CT or MRI 2. Rapidly improving symptoms at the discretion of the investigator 3. mRS \> 2 before stroke onset. 4. Massive cerebral infarction (infarct size greater than one-third of the blood middle cerebral artery supply area) suggested by CT. 5. Known contraindication to imaging with contrast agents 6. Planned adjunct intra-arterial (IA) thrombolysis during or after endovascular treatment (EVT). 7. Secondary transfer from a primary stroke center 8. Any terminal illness such that patient would not be expected to survive more than one year 9. Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study 10. Pregnant women

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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

    5 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

  • Beijing Tiantan Hospital, Capital Medical Universiity

    Beijing, Beijing Municipality, 100070, China

  • Rizhao Hospital of Traditional Chinese Medicine

    Rizhao, Shandong, 625000, China

  • Xiangtan Central Hospital

    Xiangtan, Hunan, 411100, China

  • Ya'an People's Hospital

    Ya'an, Sichuan, 625000, China

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei, 430071, China

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