Actively Recruiting
Safety and Tolerability of Adjunctive TBO-309 in Reperfusion for Stroke
Led by The Florey Institute of Neuroscience and Mental Health · Updated on 2025-12-01
80
Participants Needed
7
Research Sites
135 weeks
Total Duration
On this page
Sponsors
T
The Florey Institute of Neuroscience and Mental Health
Lead Sponsor
N
Neuroscience Trials Australia
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Tolerability of Adjunctive TBO-309 in Reperfusion for Stroke
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient aged 18 years or more
- Patient has an acute ischaemic stroke
- Patient will be treated with either intravenous thrombolysis (alteplase or tenecteplase) alone or with endovascular thrombectomy for large vessel occlusion
- Patient presented within 6 hours of stroke onset or between 6-24 hours with imaging showing salvageable brain tissue
- Patient has at least a mild grade of neurological impairment (NIHSS of 5 or more)
- Patient has an estimated pre-stroke modified Rankin Scale (mRS) of less than 4
You will not qualify if you...
- Advanced dementia or severe pre-stroke disability (mRS score 4-5)
- Glasgow Coma Score (GCS) between 3 and 5
- Large well-defined ischaemic lesion covering more than one third of the middle cerebral artery territory
- High likelihood of needing stent insertion requiring additional antithrombotic therapy
- Uncontrolled hypertension (systolic >180 or diastolic >110) despite treatment
- Intracerebral hemorrhage within last 90 days
- Myocardial infarction or stroke within last 30 days
- Life expectancy less than 90 days due to underlying disease
- Contraindication to thrombolysis or intravenous contrast agents
- Current treatment with dual antiplatelet therapy or anticoagulants
- Known severe liver disease or bleeding disorders
- Recent 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
- Participation in another interventional clinical trial
- Inability to provide informed consent prior to study interventions
- Study drug cannot be administered within one hour of thrombolytic drug bolus
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 7 locations
1
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
Actively Recruiting
2
Liverpool Hospital
Liverpool, New South Wales, Australia, 2170
Actively Recruiting
3
John Hunter Hospital
New Lambton Heights, New South Wales, Australia, 2305
Actively Recruiting
4
Prince of Wales Hospital
Randwick, New South Wales, Australia, 2031
Actively Recruiting
5
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Actively Recruiting
6
Eastern Health- Box Hill Hospital
Box Hill, Victoria, Australia, 3128
Actively Recruiting
7
Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050
Actively Recruiting
Research Team
C
Candice Delcourt, Dr
CONTACT
M
Michele Sallaberger
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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