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New drug aims to stop strokes from coming back

NCT ID NCT05363397

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a new drug called TBO-309, which helps prevent blood clots, in people having a stroke. It is given alongside standard treatments like clot-busting drugs or mechanical clot removal. The main goal is to see if it is safe, especially regarding bleeding in the brain, and to find the right dose. About 80 adults with acute ischemic stroke will take part.

What this could mean

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

Active substance
TBO-309 (antiplatelet drug)
What this could lead to
If successful, this could lead to a new treatment that reduces the risk of arteries re-blocking after standard stroke therapy, improving recovery.
What could go wrong
This is an early Phase 2 safety study with only 80 participants, so it may not prove effectiveness. The drug also carries a 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

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 80 people

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

Started

Sep 2023

Expected to finish

May 2026

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. Patient aged 18 years or more 2. Patient has an acute ischaemic stroke 3. Patient will be treated with either: 1. Intravenous thrombolysis (IVT) with alteplase or tenecteplase for a diagnosis of AIS that is confirmed by CT imaging; alone/OR WITH 2. Endovascular Thrombectomy (EVT) for large vessel occlusion (LVO) in the internal carotid artery, middle cerebral artery (M1 segment), middle cerebral artery (M2 segment) or with tandem occlusion of both the cervical carotid and intracranial large arteries who either: i. presented within 6 hours of stroke onset OR ii. presented between 6-24 hours after they were last known to be well and clinical observations and either CT perfusion or MRI features indicate the presence of salvageable brain tissue, defined as ischaemic core \<70mL with a mismatch ratio \>1.8 and absolute mismatch \>15mL. 4. Patient has at least a mild grade of neurological impairment i.e. NIHSS of 5 or more 5. Patient has an estimated pre-stroke mRS of less than 4 Exclusion Criteria 1. Patient is considered unlikely to benefit from study intervention defined by one of the following: 1. Advanced dementia 2. Severe pre-stroke disability (mRS score 4-5) 3. Glasgow Coma Score (GCS) 3 to 5 4. Evidence of a large well-defined ischaemic lesion measuring more than one third of the MCA territory 2. High likelihood of undergoing stent insertion and requiring additional antithrombotic(s) 3. Uncontrolled hypertension (SBP \>180 or DBP \>110, refractory to medical therapy) 4. ICH within the last 90 days 5. Myocardial infarction or stroke within the last 30 days 6. Patient has an underlying disease process with a life expectancy of \<90 days 7. Contraindication to thrombolysis i.e. increased bleeding risk 8. Contraindication to intravenous contrast agents including renal impairment or allergy 9. Known treatment with dual antiplatelet therapy or anticoagulant medication 10. Known severe liver disease 11. Known bleeding disorder 12. Cardiopulmonary resuscitation or arterial puncture at non-compressible site or lumbar puncture within 7 days 13. Another medical illness or social circumstance that may interfere with outcome assessments and follow-up 14. Known or suspected pregnancy 15. Patients currently participating in another interventional clinical trial 16. Informed consent unable to be obtained from the patient or their Person Responsible/Medical Treatment Decision Maker prior to study interventions 17. Study drug cannot be given within one hour of thrombolytic drug bolus

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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

    7 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

  • Eastern Health- Box Hill Hospital

    RECRUITING

    Box Hill, Victoria, 3128, Australia

  • John Hunter Hospital

    RECRUITING

    New Lambton Heights, New South Wales, 2305, Australia

  • Liverpool Hospital

    RECRUITING

    Liverpool, New South Wales, 2170, Australia

  • Prince of Wales Hospital

    RECRUITING

    Randwick, New South Wales, 2031, Australia

  • Royal Adelaide Hospital

    RECRUITING

    Adelaide, South Australia, 5000, Australia

  • Royal Melbourne Hospital

    RECRUITING

    Parkville, Victoria, 3050, Australia

  • Royal Prince Alfred Hospital

    RECRUITING

    Camperdown, New South Wales, 2050, Australia

More trials for these conditions

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