Actively Recruiting
Safety, Tolerability and Efficacy of Adjunctive TBO-309 in Reperfusion for Stroke With Tandem Occlusion
Led by ThromBio Pty. Ltd. · Updated on 2025-11-25
78
Participants Needed
2
Research Sites
64 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety, Tolerability and Efficacy of Adjunctive TBO-309 in Reperfusion for Stroke With Tandem Occlusion
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient aged 18 years or more
- Acute ischemic stroke due to tandem occlusion including large vessel occlusion in the intracranial anterior circulation and presumed atherosclerotic occlusion of the cervical internal carotid artery origin
- CT perfusion shows salvageable brain tissue with ischaemic core less than 70 mL, mismatch ratio greater than 1.8, and absolute mismatch over 15 mL
- At least mild neurological impairment with NIHSS score greater than 4
- Estimated pre-stroke modified Rankin Scale (mRS) less than 4
You will not qualify if you...
- Advanced dementia or severe pre-stroke disability (mRS 4-5)
- Glasgow Coma Scale score between 3 and 5
- Large ischaemic lesion involving more than one third of the middle cerebral artery territory
- Uncontrolled hypertension with systolic blood pressure above 180 or diastolic above 110 despite medication
- Intracranial hemorrhage within the last 90 days
- Myocardial infarction or stroke within the last 30 days
- Underlying disease with life expectancy less than 90 days
- Current treatment with anticoagulants
- Severe liver disease
- Known bleeding disorders
- Cardiopulmonary resuscitation, arterial puncture at non-compressible site, or lumbar puncture within 7 days
- Other medical or social conditions interfering with assessments and follow-up
- Known or suspected pregnancy
- Current participation in another interventional clinical trial
- Inability to provide informed consent or have a responsible person consent prior to study interventions
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
John Hunter Hospital
Newcastle, New South Wales, Australia, 2305
Actively Recruiting
2
Royal North Shore Hospital
St Leonards, New South Wales, Australia, 2065
Not Yet Recruiting
Research Team
F
Ferdinand Miteff - Interventional Neurologist, RACP, CCINR
CONTACT
C
Candice Delcourt, MD, PhD and FRACP
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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