Status:
RECRUITING
Safety and Tolerability of Adjunctive TBO-309 in Reperfusion for Stroke
Lead Sponsor:
The Florey Institute of Neuroscience and Mental Health
Collaborating Sponsors:
Neuroscience Trials Australia
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ischa...
Detailed Description
Stroke is a leading cause of disability worldwide, with most strokes in Australia being Acute ischaemic stroke (AIS). AIS is caused by a severe blockage of an artery leading to immediate reduced blood...
Eligibility Criteria
Inclusion
- 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;
- alone/OR WITH
- 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:
- i. presented within 6 hours of stroke onset
- OR
- ii. presented between 6-24 hours after they were last known to be well and clinical observations and either CT perfusion or MRI features indicate the presence of salvageable brain tissue, defined as ischaemic core \<70mL with a mismatch ratio \>1.8 and absolute mismatch \>15mL.
- 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
- 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
- High likelihood of undergoing stent insertion and requiring additional antithrombotic(s)
- Uncontrolled hypertension (SBP \>180 or DBP \>110, refractory to medical therapy)
- ICH within the last 90 days
- Myocardial infarction or stroke within the last 30 days
- Patient has an underlying disease process with a life expectancy of \<90 days
- Contraindication to thrombolysis i.e. increased bleeding risk
- Contraindication to intravenous contrast agents including renal impairment or allergy
- Known treatment with dual antiplatelet therapy or anticoagulant medication
- Known severe liver disease
- Known bleeding disorder
- Cardiopulmonary resuscitation or arterial puncture at non-compressible site or lumbar puncture within 7 days
- Another medical illness or social circumstance that may interfere with outcome assessments and follow-up
- Known or suspected pregnancy
- Patients currently participating in another interventional clinical trial
- Informed consent unable to be obtained from the patient or their Person Responsible/Medical Treatment Decision Maker prior to study interventions
- Study drug cannot be given within one hour of thrombolytic drug bolus
Exclusion
Key Trial Info
Start Date :
September 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05363397
Start Date
September 27 2023
End Date
May 1 2026
Last Update
December 1 2025
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
2
Liverpool Hospital
Liverpool, New South Wales, Australia, 2170
3
John Hunter Hospital
New Lambton Heights, New South Wales, Australia, 2305
4
Prince of Wales Hospital
Randwick, New South Wales, Australia, 2031