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Could a Late-Stage clot buster help stroke patients without surgery?

NCT ID NCT07168278

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests whether the clot-busting drug tenecteplase can improve recovery in people who have a major stroke caused by a large blocked artery, but who cannot have a procedure to remove the clot. The trial includes 794 adults who arrive at the hospital 4.5 to 24 hours after their stroke started. Participants receive either tenecteplase or standard medical care, and the main goal is to see if more people are independent at 90 days.

What this could mean

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

Active substance
Tenecteplase (a clot-busting drug)
What this could lead to
If it works, this could provide a treatment option for stroke patients who miss the early window or cannot get mechanical clot removal.
What could go wrong
This is a large phase 3 trial, but tenecteplase carries a risk of bleeding, and the benefit in this later time window (4.5-24 hours) is unproven.

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 794 people

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

Expected to start

Nov 2025

An estimate. Start dates often move.

Expected to finish

May 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: * Age 18 years or greater * Acute ischemic stroke presenting in the 4.5 to 24 hour window from last seen well (including wake-up stroke and no witness stroke). * Prestroke mRS 0-2 * NIHSS 6 to 25 * Aspect ≥ 7 * ICA terminus, M1, dominant M2 occlusion on CTA or MRA * Clinical-imaging mismatch assessed by investigator * Patients with no access to EVT at the time of randomization Exclusion Criteria: * Current or past history of significant bleeding over the past 6 months; * History of intracranial hemorrhage (including possible subarachnoid hemorrhage or subarachnoid hemorrhage due to an aneurysm) or evidence or suspected intracranial hemorrhage; * Known bleeding tendency; * Recent severe or dangerous bleeding, or active ulcerative gastrointestinal disease; * History of central nervous system injury (e.g., intracranial tumor, aneurysm, or arteriovenous malformation, intracranial or spinal surgery), or recent head injury; * Tumors that increase risk of bleeding; * Severe liver dysfunction, including liver failure, cirrhosis, portal hypertension (esophageal varices), and active hepatitis; * Know arterial / venous malformation or aneurysm; * Bacterial endocarditis, pericarditis, or acute pancreatitis; * Patients receiving effective anticoagulant therapy (vitamin K antagonists with INR \> 1.3, or other oral anticoagulants exceeding the upper limit of the corresponding standard range); * Heparin use within the past 48 hours and prothrombin time exceeding the upper limit of the standard range; * Over the past 3 months, undergone major surgery, organ biopsy, or suffered a serious injury; * Over the past 2 weeks, receiving prolonged ( \>2 minutes) cardiopulmonary resuscitation, childbirth, or non-stressful vascular puncture (such as subclavian or jugular vein puncture); * Stroke episode occurred with epileptic seizure; * History of stroke comorbid with diabetes; * History of stroke over the past 3 months; * Acute bleeding tendency, including platelet count below 100×10⁹/L or other conditions; * SBP \>185 mmHg or DBP \>110 mmHg, or requiring intensive treatment (intravenous antihypertensive drugs) to lower blood pressure to within limits; * Blood glucose \<2.8 mmol/L or \>22.2 mmol/L (\<50 mg/dL or \>400 mg/dL); * Patient life expectancy of less than 1 year; * Simultaneous occlusion of multiple blood vessels, defined as bilateral MCAs or MCAs combined with the basilar artery; * Pregnant women or nursing mothers; * Patients with a low likelihood of 3-month follow-up; * Over the past 3 months participated in other interventional clinical trials.

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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 University of Science and Technology of China

    Hefei, Anhui, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.