Safety, Tolerability and Efficacy of Adjunctive TBO-309 in Reperfusion for Stroke With Tandem Occlusion

Launched by THROMBIO PTY. LTD. · Feb 3, 2025

Keywords

ClinConnect Summary

The Co-STAR trial is a clinical study designed to evaluate the safety and effectiveness of a medication called TBO-309 for patients experiencing a type of stroke known as acute ischemic stroke with tandem occlusion. In this trial, eligible participants will receive TBO-309 while undergoing a procedure to remove blockages in their blood vessels. The main goal is to see if TBO-309 can help keep the blood vessels open without causing harmful bleeding in the brain.

To be part of this study, participants must be at least 18 years old and have a specific type of stroke caused by blockages in both the main artery in the neck and a branch in the brain. They should also show some signs of neurological impairment but not have severe disabilities or other serious health issues that would make it unlikely for them to benefit from the treatment. Throughout the trial, participants will be closely monitored to ensure their safety and assess how well the treatment is working. This study is currently not recruiting participants, but it aims to gather important information that could help improve stroke treatment in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patient aged 18 years or more
• • 2. Patient has an AIS due to tandem occlusion, including large vessel occlusion (LVO) within the intra-cranial anterior circulation and presumed atherosclerotic occlusion of the cervical internal carotid artery origin
• • 3. CT perfusion indicates 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 (NIHSS \>4)
• • 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 middle cerebral artery (MCA) territory
• • 2. Uncontrolled hypertension (SBP \>180 or DBP \>110, refractory to medical therapy)
• • 3. Intracranial haemorrhage within the last 90 days
• • 4. Myocardial infarction or stroke within the last 30 days
• • 5. Patient has an underlying disease process with a life expectancy of \<90 days
• • 6. Known treatment with anticoagulants
• • 7. Known severe liver disease
• • 8. Known bleeding disorder
• • 9. Cardiopulmonary resuscitation or arterial puncture at non-compressible site or lumbar puncture within 7 days
• • 10. Another medical illness or social circumstance that may interfere with outcome assessments and follow-up
• • 11. Known or suspected pregnancy
• • 12. Patients currently participating in another interventional clinical trial
• • 13. Informed consent unable to be obtained from the patient or their Person Responsible/Medical Treatment Decision Maker prior to study interventions