Safety and Tolerability of Adjunctive TBO-309 in Reperfusion for Stroke

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.

NCT Number	NCT05363397
Lead Sponsor	The Florey Institute of Neuroscience and Mental Health Collaborators: Neuroscience Trials Australia
Conditions	Acute Ischemic Stroke
Enrollment	80 participants
Start Date	2023-09-27
Primary Completion	2026-02-01 (estimated)
Study Completion	2026-05-01 (estimated)
Updated on ClinicalTrials.gov	2025-12-01