Adding TBO-309 to reperfusion treatment for acute ischemic stroke.
Official title: Safety and Tolerability of Adjunctive TBO-309 in Reperfusion for Stroke
Run by The Florey Institute of Neuroscience and Mental Health · NCT05363397 · Data updated 2026-11-12
This trial will test whether giving the antiplatelet drug TBO-309 together with clot-dissolving or clot-removal treatment is safe for adults who have just had an acute ischemic stroke.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | The Florey Institute of Neuroscience and Mental Health Academic / other |
| Locations | 7 sites (Camperdown, New South Wales and 6 other locations) |
| Status | Recruiting |
| Started | September 27, 2023 |
| Main results expected | February 1, 2026 |
| Study ends | May 1, 2026 |
| Registry record updated | December 1, 2025 |
| Trial ID | NCT05363397 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with acute ischemic stroke who are treated with IV thrombolysis (alteplase or tenecteplase) with or without endovascular thrombectomy, have NIHSS ≥5, and present within the reperfusion time windows (≤6 hours or 6–24 hours with favorable perfusion imaging) are the intended candidates.
✕Probably not a fit
Patients with hemorrhagic stroke, those not eligible for IV thrombolysis or EVT, people with very mild deficits (NIHSS <5), or those with contraindications to antiplatelet/anticoagulant therapy are unlikely to benefit from this adjunctive treatment.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
STARS is a prospective, multicentre, open-label, dose-escalation Phase IIa trial enrolling adults with acute ischemic stroke who receive intravenous thrombolysis with or without endovascular thrombectomy. Participants will receive one of several escalating doses of TBO-309 in addition to standard reperfusion therapy, with close monitoring for safety events, especially intracranial hemorrhage. TBO-309 is a selective, ATP-competitive PI3Kβ inhibitor designed to block platelet activation and aggregation while sparing normal haemostasis. The primary focus is tolerability and safety compared to expected hemorrhage rates after standard reperfusion care.
Why it matters
Potential benefit: If successful, adding TBO-309 could lower the risk of artery re-blockage after reperfusion and improve restoration of blood flow, potentially reducing disability from stroke.
How similar studies have gone: Previous attempts to add antiplatelet agents around reperfusion have shown mixed results because of bleeding risk, so while adjunctive antiplatelet therapy has precedent, TBO-309's selective PI3Kβ mechanism is novel and largely untested in this setting.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia Recruiting -
Liverpool Hospital
Liverpool, New South Wales, Australia Recruiting -
John Hunter Hospital
New Lambton Heights, New South Wales, Australia Recruiting -
Prince of Wales Hospital
Randwick, New South Wales, Australia Recruiting -
Royal Adelaide Hospital
Adelaide, South Australia, Australia Recruiting -
Eastern Health- Box Hill Hospital
Box Hill, Victoria, Australia Recruiting
Show 1 more location
-
Royal Melbourne Hospital
Parkville, Victoria, Australia Recruiting
Study contacts
- Study coordinator: Candice Delcourt, Dr
- Email: cdelcourt@georgeinstitute.org.au
- Phone: +61 2 8052 4601
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.