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

Prior treatment

• Known treatment with dual antiplatelet therapy or anticoagulant medication
• 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

Other illness

• 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
• Uncontrolled hypertension (SBP \>180 or DBP \>110, refractory to medical therapy)
• 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 severe liver disease
• Known bleeding disorder
• Another medical illness or social circumstance that may interfere with outcome assessments and follow-up

Other

• High likelihood of undergoing stent insertion and requiring additional antithrombotic(s)
• ICH within the last 90 days
• Cardiopulmonary resuscitation or arterial puncture at non-compressible site or lumbar puncture within 7 days
• Known or suspected pregnancy
• Patients currently participating in another interventional clinical trial

• 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:
  • presented within 6 hours of stroke onset
  • OR
  • 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