NCT05363397 Safety and Tolerability of Adjunctive TBO-309 in Reperfusion for Stroke

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.

This trial targets 80 participants in total. It began in 2023-09-27 with a primary completion date of 2026-02-01.

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 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 Criteria

Inclusion Criteria 1. Patient aged 18 years or more 2. Patient has an acute ischaemic stroke 3. Patient will be treated with either: 1. Intravenous thrombolysis (IVT) with alteplase or tenecteplase for a diagnosis of AIS that is confirmed by CT imaging; alone/OR WITH 2. 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. 4. Patient has at least a mild grade of neurological impairment i.e. NIHSS of 5 or more 5. Patient has an estimated pre-stroke mRS of less than 4 Exclusion Criteria 1. Patient is considered unlikely to benefit from study intervention defined by one of the following: 1. Advanced dementia 2. Severe pre-stroke disability (mRS score 4-5) 3. Glasgow Coma Score (GCS) 3 to 5 4. Evidence of a large well-defined ischaemic lesion measuring more than one third of the MCA territory 2. High likelihood of undergoing stent insertion and requiring additional antithrombotic(s) 3. Uncontrolled hypertension (SBP \>180 or DBP \>110, refractory to medical therapy) 4. ICH within the last 90 days 5. Myocardial infarction or stroke within the last 30 days 6. Patient has an underlying disease process with a life expectancy of \<90 days 7. Contraindication to thrombolysis i.e. increased bleeding risk 8. Contraindication to intravenous contrast agents including renal impairment or allergy 9. Known treatment with dual antiplatelet therapy or anticoagulant medication 10. Known severe liver disease 11. Known bleeding disorder 12. Cardiopulmonary resuscitation or arterial puncture at non-compressible site or lumbar puncture within 7 days 13. Another medical illness or social circumstance that may interfere with outcome assessments and follow-up 14. Known or suspected pregnancy 15. Patients currently participating in another interventional clinical trial 16. Informed consent unable to be obtained from the patient or their Person Responsible/Medical Treatment Decision Maker prior to study interventions 17. Study drug cannot be given within one hour of thrombolytic drug bolus

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