Tests TBO-309 with clot removal in stroke patients with tandem blockages
Tests TBO-309 alongside thrombectomy and stenting in adults with ischemic stroke.
Plain-language title generated from the registry record
Registry title: Safety, Tolerability and Efficacy of Adjunctive TBO-309 in Reperfusion for Stroke With Tandem Occlusion
Key facts
- Where
- Newcastle and St Leonards, AustraliaSee the 2 sites
- Phase
- Phase 2
Where in Australia
- John Hunter HospitalNewcastle, AustraliaTaking people
- Royal North Shore HospitalSt Leonards, AustraliaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- ThromBio Pty. Ltd.
- Trial code
- NCT06813651
- Record updated
- 25 November 2025
- Original description
Co-STAR is a multicenter, prospective, open-label, Bayesian Optimal Phase 2 (BOP2) trial that aims to assess the safety and efficacy of adjunctive intravenous TBO-309 in Acute Ischaemic Stroke (AIS) patients with tandem occlusion receiving intra-cranial endovascular thrombectomy (EVT) and acute extracranial carotid artery stenting.Read full original descriptionShow less
Safety, Tolerability and Efficacy of Adjunctive TBO-309 in Reperfusion for Stroke With Tandem Occlusion
Co-STAR is a multicenter, prospective, open-label, Bayesian Optimal Phase 2 (BOP2) trial that aims to assess the safety and efficacy of adjunctive intravenous TBO-309 in Acute Ischaemic Stroke (AIS) patients with tandem occlusion receiving intra-cranial endovascular thrombectomy (EVT) and acute extracranial carotid artery stenting.
Co-STARS study will test the hypothesis that patients with tandem occlusion treated with EVT and acute stenting in conjunction with TBO-309 will:
* have persistent stent patency without requiring rescue therapy with GPIIb/IIIa inhibitors and * not experience high rates of symptomatic intra-cranial haemorrhage (sICH).
Patients with tandem occlusion undergoing EVT and acute stenting will receive intravenous TBO-309 bolus and infusion. TBO-309 is a potent, selective and ATP competitive PI3K[beta] inhibitor which reduces platelet activation adhesion/aggregation particularly under conditions of disturbed blood flow and promotes platelet disaggregation. By targeting PI3K[beta], TBO-309 specifically inhibits thrombosis whilst minimizing the impact on normal hemostasis.
Inclusion: Patient aged 18 years or more; Patient has an AIS due to tandem occlusion, including large vessel occlusion (LVO) within the intra-cranial anterior circulation and presumed atherosclerotic occlusion of the cervical internal carotid artery origin; CT perfusion indicates the presence of salvageable brain tissue, defined as ischaemic core <70mL with a mismatch ratio >1.8 and absolute mismatch >15mL; Patient has at least a mild grade of neurological impairment (NIHSS >4); Patient has an estimated pre-stroke mRS of less than 4.
Exclusion: Known treatment with anticoagulants; Informed consent unable to be obtained from the patient or their Person Responsible/Medical Treatment Decision Maker prior to study interventions; Patient is considered unlikely to benefit from study intervention defined by one of the following:; Advanced dementia; Severe pre-stroke disability (mRS score 4-5); Glasgow Coma Score (GCS) 3 to 5; Evidence of a large well-defined ischaemic lesion measuring more than one third of the middle cerebral artery (MCA) territory; Uncontrolled hypertension (SBP >180 or DBP >110, refractory to medical therapy); Intracranial haemorrhage within the last 90 days; Myocardial infarction or stroke within the last 30 days; Patient has an underlying disease process with a life expectancy of <90 days; Known severe liver disease; Known bleeding disorder; Another medical illness or social circumstance that may interfere with outcome assessments and follow-up; Cardiopulmonary resuscitation or arterial puncture at non-compressible site or lumbar puncture within 7 days; Known or suspected pregnancy; Patients currently participating in another interventional clinical trial.