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RECRUITINGPhase 2INTERVENTIONAL

Safety, Tolerability and Efficacy of Adjunctive TBO-309 in Reperfusion for Stroke With Tandem Occlusion

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Patient aged 18 years or more 2. 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 3. CT perfusion indicates 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 (NIHSS \>4) 5. Patient has an estimated pre-stroke mRS of less than 4 Who Should NOT Join This Trial: 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 middle cerebral artery (MCA) territory 2. Uncontrolled hypertension (SBP \>180 or DBP \>110, refractory to medical therapy) 3. Intracranial haemorrhage within the last 90 days 4. Myocardial infarction or stroke within the last 30 days 5. Patient has an underlying disease process with a life expectancy of \<90 days 6. Known treatment with anticoagulants 7. Known severe liver disease 8. Known bleeding disorder 9. Cardiopulmonary resuscitation or arterial puncture at non-compressible site or lumbar puncture within 7 days 10. Another medical illness or social circumstance that may interfere with outcome assessments and follow-up 11. Known or suspected pregnancy 12. Patients currently participating in another interventional clinical trial 13. willing to sign a consent form unable to be obtained from the patient or their Person Responsible/Medical Treatment Decision Maker prior to study interventions Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Patient aged 18 years or more 2. 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 3. CT perfusion indicates 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 (NIHSS \>4) 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 middle cerebral artery (MCA) territory 2. Uncontrolled hypertension (SBP \>180 or DBP \>110, refractory to medical therapy) 3. Intracranial haemorrhage within the last 90 days 4. Myocardial infarction or stroke within the last 30 days 5. Patient has an underlying disease process with a life expectancy of \<90 days 6. Known treatment with anticoagulants 7. Known severe liver disease 8. Known bleeding disorder 9. Cardiopulmonary resuscitation or arterial puncture at non-compressible site or lumbar puncture within 7 days 10. Another medical illness or social circumstance that may interfere with outcome assessments and follow-up 11. Known or suspected pregnancy 12. Patients currently participating in another interventional clinical trial 13. Informed consent unable to be obtained from the patient or their Person Responsible/Medical Treatment Decision Maker prior to study interventions

Treatments Being Tested

DRUG

TBO-309: 60 mg

TBO-309 is a potent, selective and ATP competitive PI3Kβ inhibitor which blocks platelet activation adhesion/aggregation and promotes platelet disaggregation. By targeting PI3Kβ, TBO-309 specifically inhibits thrombosis whilst minimizing the impact on normal haemostasis.

DRUG

TBO-309: 120 mg

TBO-309 is a potent, selective and ATP competitive PI3Kβ inhibitor which blocks platelet activation adhesion/aggregation and promotes platelet disaggregation. By targeting PI3Kβ, TBO-309 specifically inhibits thrombosis whilst minimizing the impact on normal haemostasis.

DRUG

TBO-309: 30 mg

TBO-309 is a potent, selective and ATP competitive PI3Kβ inhibitor which blocks platelet activation adhesion/aggregation and promotes platelet disaggregation. By targeting PI3Kβ, TBO-309 specifically inhibits thrombosis whilst minimizing the impact on normal haemostasis.

Locations (2)

John Hunter Hospital
Newcastle, New South Wales, Australia
Royal North Shore Hospital
St Leonards, New South Wales, Australia