RecruitingPhase 2NCT05363397

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

Sponsor

The Florey Institute of Neuroscience and Mental Health

Enrollment

80 participants

Start Date

Sep 27, 2023

Study Type

INTERVENTIONAL

Conditions

Acute Ischemic Stroke

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria11

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 Criteria21

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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGTBO-309

TBO-309 is a potent, selective and ATP competitive PI3Kβ inhibitor which blocks platelet activation adhesion/aggregation and promotes platelet disaggregation, thereby specifically inhibiting thrombosis without interfering with normal haemostasis.