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
The Florey Institute of Neuroscience and Mental Health
Lead sponsor
Neuroscience Trials Australia
Collaborator