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Stroke drug boost: could tenecteplase finish the job?

NCT ID NCT07471282

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether giving a clot-busting drug called tenecteplase directly into the brain artery can help stroke patients who still have blocked blood flow after a standard clot removal procedure. About 344 adults with a major stroke will be randomly assigned to receive either the drug or a placebo. The goal is to see if the drug improves recovery and reduces disability 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 better way to restore blood flow and improve recovery for stroke patients whose arteries aren't fully cleared by the standard procedure.
What could go wrong
This is a Phase 3 trial, but it's still early to know if the drug will be effective or safe. There is a risk of bleeding in the brain, and the results may not apply to all stroke types.

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 344 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

Mar 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. Age ≥ 18 years; 2. Time from symptom onset or last known well to randomization within 24 hours; 3. Clinical diagnosis of acute ischemic stroke caused by acute occlusion of the intracranial anterior circulation large vessels confirmed by CTA/MRA/DSA, including occlusion of the intracranial segment of the internal carotid artery, the M1 or M2 segments of the middle cerebral artery, with or without concomitant occlusion of the ipsilateral extracranial segment of the internal carotid artery; 4. NIHSS score ≥ 6, and meeting the current guidelines for mechanical thrombectomy; 5. Anterior circulation large vessel stroke due to occlusion of the intracranial ICA, MCA M1, or M2 segments; 6. Pre-stroke mRS score ≤ 1; 7. ASPECTS score ≥ 6; 8. Post-mechanical thrombectomy status with 2b ≤ eTICI \< 3, and the operator has decided not to attempt further mechanical recanalization of the occluded vessel; 9. No more than 3 passes with the thrombectomy device; 10. Signed informed consent obtained from the patient or their legal guardian. Exclusion Criteria: 1. Contraindications to intravenous thrombolysis (excluding time-based criteria); 2. DSA post-thrombectomy indicating dissection of the occluded artery, or intra-procedural flat-panel CT suggesting local hemorrhage or significant contrast extravasation; 3. Baseline NIHSS score not obtained; 4. Severe allergy or absolute contraindication to iodinated contrast media; 5. Systolic blood pressure ≥ 185 mmHg or diastolic blood pressure ≥ 110 mmHg, refractory to antihypertensive medication; 6. Blood glucose \< 50 mg/dL (2.8 mmol/L) or \> 400 mg/dL (22.2 mmol/L); 7. Platelet count \< 50 × 10⁹/L, or APTT \> 40 s, or PT \> 15 s; 8. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency; or current use of oral anticoagulants with INR \> 1.7; 9. Severe renal failure, defined as serum creatinine \> 3.0 mg/dL (or 265.2 μmol/L) or glomerular filtration rate \[GFR\] \< 30 mL/min, or requiring hemodialysis or peritoneal dialysis; 10. Patient unlikely to complete the 90-day follow-up (e.g., no fixed address, palliative care patient, etc.); 11. Suspected vasculitis or septic embolism; 12. Suspected aortic dissection; 13. Pre-existing neurological or psychiatric disease that would interfere with the assessment of outcomes; 14. Pregnancy or lactation; 15. Current participation in another clinical trial that could interfere with this study; 16. Any other condition deemed by the investigator to make the patient unsuitable for participation or to pose a significant risk 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

    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 China Medical University

    Shenyang, Liaoning, 110000, China

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