STARS is a prospective, multicentre, open-label, dose escalation, Phase IIa study to assess the safety and tolerability of TBO-309, an adjuvant antiplatelet therapy, in patients with AIS.
Acute ischaemic stroke (AIS) is caused by a severe blockage of an artery leading to immediate reduced blood flow to part of the brain. Standard therapies target the blocked artery by either dissolving the blockage or removing the blockage. However, even after successful treatment, re-blockage of arteries can occur. The use of an antiplatelet therapy, TBO-309, in addition to standard therapies offers the possibility of improved restoration of blood flow and reduced rates of artery re-blockage.
Patient aged 18 years or more
Patient has an acute ischaemic stroke
Intravenous thrombolysis (IVT) with alteplase or tenecteplase for a diagnosis of AIS that is confirmed by CT imaging;
Patient has at least a mild grade of neurological impairment i.e. NIHSS of 5 or more
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 MCA territory
Sequential
TBO-309
DrugTBO-309 is a potent, selective and ATP competitive PI3Kβ inhibitor which blocks platelet activation adhesion/aggregation and promotes platelet disaggregation, thereby specifically inhibiting thrombosis without interfering with normal haemostasis.
Proportion of patients with ICH within 24-36 hours of study drug (TBO-309) commencement.
Proportion of patients with ICH within 24-36 hours of study drug (TBO-309) commencement. ICH is defined as parenchymal haemorrhage (PH) type II based on The Heidelberg Bleeding Classification or any intracranial haemorrhage leading to clinical deterioration i.e. an increase in NIHSS of 4 points or more, on post-intervention brain MRI with MRA or multimodal CT scan (see appendix 2 and 3). This definition allows the inclusion of any clinically and radiologically significant haemorrhage with the rate of expected ICH in this patient population estimated to be up to 8%
All bleeding
All bleeding within 72 hours of study drug (TBO-309) administration according to a modified WHO scale
All ICH
All ICH demonstrated on 24-36 hours imaging (recommended in patients who did not have the 2-6 hours imaging)
All intracerebral hemorrhage (ICH)
All ICH as demonstrated on CT/MRI up to 90 days
All bleeding
All bleeding reported up to 90 days according to a modified WHO scale
Recanalisation rate
CT Angiogram (CTA) or MR Angiogram (MRA) assessment 2-6 hours post study drug commencement in patients with visible vessel occlusion who do not receive endovascular thrombectomy to measure recanalisation rate by the Arterial Occlusive Lesion (AOL) scale
Reperfusion rates
Reperfusion rates by expanded Thrombolysis in Cerebral Infarction scale (eTICI) 2b50 or better (i.e. 50% to 100%) at the initial catheter angiogram in patients receiving endovascular thrombectomy and at the end after patients have received endovascular thrombectomy.
Infarct volume
Infarct volume 24-36 hours post study drug commencement measured by Diffusion Weighted Imaging (DWI) MRI or CT scan
NIHSS score
Quantifies stroke severity
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The Florey Institute of Neuroscience and Mental Health
Lead sponsor
Neuroscience Trials Australia
Collaborator
