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Tests treatment safety and results for Ischemic Stroke
Official title Safety, Tolerability and Efficacy of Adjunctive TBO-309 in Reperfusion for Stroke With Tandem Occlusion
ClinicalTrials.gov ID: NCT06813651
What this study is testing
What is TBO-309: 60 mg?
TBO-309: 60 mg is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for ischemic stroke.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Co-STAR is a multicenter, prospective, open-label, Bayesian Optimal Phase 2 (BOP2) trial that aims to assess the safety and efficacy of adjunctive intravenous TBO-309 in Acute Ischaemic Stroke (AIS) patients with tandem occlusion receiving intra-cranial endovascular thrombectomy (EVT) and acute extracranial carotid artery stenting. Co-STARS study will test the hypothesis that patients with tandem occlusion treated with EVT and acute stenting in conjunction with TBO-309 will: have persistent stent patency without requiring rescue therapy with GPIIb/IIIa inhibitors and not experience high rates of symptomatic intra-cranial haemorrhage (sICH).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patient aged 18 years or more
- Patient has an AIS due to tandem occlusion, including large vessel occlusion (LVO) within the intra-cranial anterior circulation and presumed...
- CT perfusion indicates the presence of salvageable brain tissue, defined as ischaemic core \ 1.8 and absolute mismatch \>15mL.
- Patient has at least a mild grade of neurological impairment (NIHSS \>4)
- Patient has an estimated pre-stroke mRS of less than 4
You likely can't join if
- 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 middle cerebral artery (MCA) territory
- Uncontrolled hypertension (SBP \>180 or DBP \>110, refractory to medical therapy)
See the full eligibility criteria
- Patient aged 18 years or more
- 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
- CT perfusion indicates the presence of salvageable brain tissue, defined as ischaemic core \ 1.8 and absolute mismatch \>15mL.
- Patient has at least a mild grade of neurological impairment (NIHSS \>4)
- Patient has an estimated pre-stroke mRS of less than 4
- 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 middle cerebral artery (MCA) territory
- Uncontrolled hypertension (SBP \>180 or DBP \>110, refractory to medical therapy)
- Intracranial haemorrhage 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
- Known treatment with anticoagulants
- 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 treatment clinical trial
- Informed consent unable to be obtained from the patient or their Person Responsible/Medical Treatment Decision Maker prior to study interventions
The study team makes the final eligibility decision.
Where it's taking place
- Newcastle, New South Wales, Australia
- St Leonards, New South Wales, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Newcastle, New South Wales, Australia; St Leonards, New South Wales, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.