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Stroke drug combo aims to boost recovery

NCT ID NCT06949228

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 giving the clot-busting drug tenecteplase directly into the brain artery after mechanical clot removal can improve outcomes for people with acute ischemic stroke. About 132 adults aged 18-85 with large vessel blockages will be randomly assigned to receive the drug or standard care. The goal is to see if the drug helps more patients recover with little or no disability at 90 days, while monitoring for brain bleeding.

What this could mean

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

Active substance
tenecteplase
What this could lead to
If it works, this could improve recovery and reduce disability after a severe stroke by clearing remaining clots.
What could go wrong
This is an early combined Phase 2/3 trial with only 132 participants, so results may not apply to all stroke patients. There is a risk of brain bleeding from the drug.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 132 people

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

Started

Jul 2025

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 to 85 years

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 18-85 2. Anterior circulation ischemic stroke symptoms with confirmed occlusion (ICA, M1, or M2) on angiogram and mechanical thrombectomy initiated within 24 hours since last known well 3. Alberta Stroke Program Early CT Score (ASPECTS) Score ≥6 on baseline Non-contrast Head CT (NCCT) 4. Post-mechanical thrombectomy with ≤5 device passes and mTICI grade 2b or higher. 5. Ability to obtain signed informed consent prior to randomization from LAR or Subject Exclusion Criteria: 1. Premorbid modified Rankin scale (mRS) score \>1 2. Imaging evidence of hemorrhage or mass effect at baseline 3. Platelet count \<100,000 4. Active hemorrhagic diathesis, or known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency 5. Active anticoagulation treatment with novel oral anticoagulant (NOACs) taken within the last 48 hours, or INR \>1.7 6. Patients requiring active treatment with dual antiplatelet agents (e.g. proximal cervical carotid artery stenting) 7. Pregnant or lactating 8. Previous known allergy to TNK 9. Major surgery in past 30 days 10. Patient is on or requires dialysis 11. History of intracranial hemorrhage or serious head trauma at any time 12. Any condition in the opinion of the enrolling physician that would preclude the patient from participating 13. Pre-existing medical, neurological, or psychiatric disease that would confound the neurological or functional evaluation 14. Severe, uncontrolled hypertension (systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg) that is refractory to treatment 15. History of acute ischemic stroke in the last 60 days and/or has received previous treatment with a thrombolytic within the last 90 days 16. Presumed septic embolus; suspicion of bacterial endocarditis 17. Suspicion of aortic dissection 18. Intracranial neoplasm 19. Any terminal medical condition with life expectancy less than 6 months 20. Concurrent enrollment in another trial that could confound the results of this study 21. Patient is unlikely to return for 90-day follow-up. 22. Intravenous tissue plasminogen activator (tPA) administered concurrently with Intra-arterial TNK

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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

  • ProMedica Toledo Hospital

    RECRUITING

    Toledo, Ohio, 43606, United States

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