New drug aims to stop strokes from coming back
NCT ID NCT05363397
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2023
- Expected to finish
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May 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
7 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Eastern Health- Box Hill Hospital
RECRUITINGBox Hill, Victoria, 3128, Australia
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John Hunter Hospital
RECRUITINGNew Lambton Heights, New South Wales, 2305, Australia
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Liverpool Hospital
RECRUITINGLiverpool, New South Wales, 2170, Australia
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Prince of Wales Hospital
RECRUITINGRandwick, New South Wales, 2031, Australia
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Royal Adelaide Hospital
RECRUITINGAdelaide, South Australia, 5000, Australia
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Royal Melbourne Hospital
RECRUITINGParkville, Victoria, 3050, Australia
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Royal Prince Alfred Hospital
RECRUITINGCamperdown, New South Wales, 2050, Australia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can PET scans reveal hidden heart inflammation after a stroke?
- Can an implanted heart monitor catch hidden irregular heartbeats after stroke?
- China builds national watchdog for brain blood vessel devices
- Can tiny neural exosomes help the brain heal after a severe stroke?
- Can a new antibody boost recovery after severe stroke?
- After stroke, a balloon or a stent? trial tests which rescue opens blocked brain arteries better