Safety, Tolerability and Efficacy of Adjunctive TBO-309 in Reperfusion for Stroke With Tandem Occlusion
Recruiting now · Phase 2
Conditions studied: Ischemic Stroke, Tandem Occlusion
In brief
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.
Key facts
- Study ID
- NCT06813651
- Run by
- ThromBio Pty. Ltd.
- People needed
- 78
- Starts
- 2025-10-04
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2025-11-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 treatment with anticoagulants
- Known severe liver disease
- Known bleeding disorder
- Cardiopulmonary resuscitation or arterial puncture at non-compressible site or lumbar puncture within 7 days
- Another medical illness or social circumstance that may interfere with outcome assessments and follow-up
- Known or suspected pregnancy
- Patients currently participating in another interventional clinical trial
- Informed consent unable to be obtained from the patient or their Person Responsible/Medical Treatment Decision Maker prior to study interventions
Where it is running
- John Hunter Hospital — Newcastle, New South Wales, Australia (enrolling)
- Royal North Shore Hospital — St Leonards, New South Wales, Australia
Full record on ClinicalTrials.gov
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