Safety and Tolerability of Adjunctive TBO-309 in Reperfusion for Stroke (NCT05363397) | Clinical Trial Compass
RecruitingPhase 2
Safety and Tolerability of Adjunctive TBO-309 in Reperfusion for Stroke
Australia80 participantsStarted 2023-09-27
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patient aged 18 years or more
✓. Patient has an acute ischaemic stroke
✓. Patient will be treated with either:
✓. Intravenous thrombolysis (IVT) with alteplase or tenecteplase for a diagnosis of AIS that is confirmed by CT imaging;
✓. Endovascular Thrombectomy (EVT) for large vessel occlusion (LVO) in the internal carotid artery, middle cerebral artery (M1 segment), middle cerebral artery (M2 segment) or with tandem occlusion of both the cervical carotid and intracranial large arteries who either:
✓. Patient has at least a mild grade of neurological impairment i.e. NIHSS of 5 or more
✓. Patient has an estimated pre-stroke mRS of less than 4
Exclusion criteria
✕. Patient is considered unlikely to benefit from study intervention defined by one of the following:
✕. Advanced dementia
What they're measuring
1
Proportion of patients with ICH within 24-36 hours of study drug (TBO-309) commencement.
Timeframe: Within 24-36 hours of initiation of study drug
Trial details
NCT IDNCT05363397
SponsorThe Florey Institute of Neuroscience and Mental Health