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New drug could extend window for treating deadly stroke

NCT ID NCT05105633

Disease control Sponsor: University of Melbourne Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This trial is testing a drug called tenecteplase for people with a severe stroke caused by a blockage in the basilar artery at the back of the brain. About 688 participants will receive either tenecteplase or standard care within 24 hours of symptoms starting, followed by a clot-removal procedure if needed. The goal is to see if tenecteplase helps more people recover with little or no 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 given as a quick injection)
What this could lead to
If it works, this could offer a more effective clot-busting treatment for a severe type of stroke, potentially helping more people recover without disability.
What could go wrong
This is an early-to-mid stage trial, so results are not guaranteed. The drug may not improve outcomes and could increase the risk of bleeding in the brain.

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 688 people

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

Started

Nov 2021

Expected to finish

May 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: * Patients presenting with posterior circulation ischemic stroke symptoms due to partial or complete basilar artery occlusion within 24 hours from symptom onset (or clinical deterioration/coma) or the time the patient was last known to be well. * Patient's age is ≥18 years * Presence of basilar artery occlusion, proven by CT Angiography or MR Angiography. Basilar artery occlusion is defined as 'potentially retrievable' occlusion at the basilar artery. This can be a partial or complete occlusion. * Premorbid mRS ≤3 (independent function or requiring only minor domestic assistance and able to manage alone for at least 1 week). * Local legal requirements for consent have been satisfied. Exclusion Criteria: * Intracerebral hemorrhage (ICH) or other diagnosis (e.g. tumour) identified by baseline imaging. * Posterior circulation Acute Stroke Prognosis Early CT score (pc-ASPECTS) \<7 on non-contrast CT, CT Angiography source images or DWI MRI. * Significant cerebellar mass effect or acute hydrocephalus. * Established frank hypodensity on non-contrast CT indicating subacute infarction. * Bilateral extensive brainstem ischemia. * Strong suspicion of underlying intracranial atherosclerotic disease (e.g diffuse arterial calcifications, basilar stenosis) or dissection which may require immediate neuro-interventional procedure with intracranial stenting and not benefit from intravenous thrombolysis at investigator's discretion. * Pre-stroke mRS of ≥4 (indicating moderate to severe previous disability). * Other standard contraindications to intravenous thrombolysis. * Contraindication to imaging with contrast agents. * Clinically evident pregnant women. * Current participation in another research drug treatment protocol. * Known terminal illness such that the patients would not be expected to survive a year. * Planned withdrawal of care or comfort care measures. * 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.

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Conditions

The condition(s) this trial relates to.

basilar artery occlusion brain disorder cardiovascular disorder central nervous system disorder cerebrovascular disorder Ischemic Stroke nervous system disorder stroke disorder vascular disorder

As listed by the trial registrant

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

Basilar artery occlusion

How to take part

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

  1. The places running it

    17 sites in 3 countries. 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

  • Alfred Health

    RECRUITING

    Melbourne, Victoria, Australia

  • Austin Hospital

    RECRUITING

    Melbourne, Victoria, Australia

  • Bankstown-Lidcombe Hospital

    NOT_YET_RECRUITING

    Bankstown, New South Wales, Australia

  • Box Hill Hospital

    RECRUITING

    Melbourne, Victoria, Australia

  • Fiona Stanley Hospital

    RECRUITING

    Murdoch, Western Australia, 6150, Australia

  • Gold Coast Hospital

    NOT_YET_RECRUITING

    Gold Coast, Queensland, Australia

  • Grampians Health

    RECRUITING

    Ballarat, Australia

  • Hospital Geral de Fortaleza

    RECRUITING

    Fortaleza, Brazil

  • John Hunter Hospital

    NOT_YET_RECRUITING

    Newcastle, New South Wales, Australia

  • Liverpool Hospital

    RECRUITING

    Sydney, New South Wales, Australia

  • Monash Health

    NOT_YET_RECRUITING

    Melbourne, Victoria, Australia

  • Northern Hospital

    RECRUITING

    Melbourne, Australia

  • Princess Alexandra Hospital

    RECRUITING

    Woolloongabba, Queensland, 4102, Australia

  • Royal Adelaide Hospital

    RECRUITING

    Adelaide, South Australia, Australia

  • Royal Melbourne Hospital

    RECRUITING

    Melbourne, Victoria, Australia

  • Tours University Hospital

    RECRUITING

    Tours, France

  • Western Health

    RECRUITING

    Melbourne, Victoria, Australia

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