Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
A database of clinical trials and their results from Australia, New Zealand, and other countries.
account_circle
Log in
to register or update your trial
search
Search for trials
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06813651
Registration number
NCT06813651
Ethics application status
Date submitted
21/01/2025
Date registered
7/02/2025
Date last updated
10/04/2025
Titles & IDs
Public title
Safety, Tolerability and Efficacy of Adjunctive TBO-309 in Reperfusion for Stroke With Tandem Occlusion
Query!
Scientific title
Safety, Tolerability and Efficacy of Adjunctive TBO-309 in Reperfusion for Stroke With Tandem Occlusion
Query!
Secondary ID [1]
0
0
Application No. 00039
Query!
Secondary ID [2]
0
0
Co-STARS
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Co-STARS
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Ischemic Stroke
0
0
Query!
Tandem Occlusion
0
0
Query!
Condition category
Condition code
Stroke
0
0
0
0
Query!
Haemorrhagic
Query!
Stroke
0
0
0
0
Query!
Ischaemic
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - TBO-309: 60 mg
Treatment: Drugs - TBO-309: 120 mg
Treatment: Drugs - TBO-309: 30 mg
Experimental: TBO-309 - 60 mg - An intravenous (IV) bolus of TBO-309 will be administered before the acute stent procedure. The allocated dose of TBO-309 will be given IV as follows:
20% of the dose will be administered as a bolus over approximately one minute; then the remainder of the dose (80%) will be administered over 3 hours as an infusion.
Experimental: TBO-309 - 120 mg - An intravenous (IV) bolus of TBO-309 will be administered before the acute stent procedure. The allocated dose of TBO-309 will be given IV as follows:
20% of the dose will be administered as a bolus over approximately one minute; then the remainder of the dose (80%) will be administered over 3 hours as an infusion.
Experimental: TBO-309 - 30 mg - An intravenous (IV) bolus of TBO-309 will be administered before the acute stent procedure. The allocated dose of TBO-309 will be given IV as follows:
20% of the dose will be administered as a bolus over approximately one minute; then the remainder of the dose (80%) will be administered over 3 hours as an infusion.
Treatment: Drugs: TBO-309: 60 mg
TBO-309 is a potent, selective and ATP competitive PI3Kß inhibitor which blocks platelet activation adhesion/aggregation and promotes platelet disaggregation. By targeting PI3Kß, TBO-309 specifically inhibits thrombosis whilst minimizing the impact on normal haemostasis.
Treatment: Drugs: TBO-309: 120 mg
TBO-309 is a potent, selective and ATP competitive PI3Kß inhibitor which blocks platelet activation adhesion/aggregation and promotes platelet disaggregation. By targeting PI3Kß, TBO-309 specifically inhibits thrombosis whilst minimizing the impact on normal haemostasis.
Treatment: Drugs: TBO-309: 30 mg
TBO-309 is a potent, selective and ATP competitive PI3Kß inhibitor which blocks platelet activation adhesion/aggregation and promotes platelet disaggregation. By targeting PI3Kß, TBO-309 specifically inhibits thrombosis whilst minimizing the impact on normal haemostasis.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Proportion of patients achieving a composite outcome of efficacy and safety
Query!
Assessment method [1]
0
0
The primary endpoint is a composite outcome of efficacy and safety, defined by the proportion of patients who 1) avoid intra-procedural GPIIb/IIIa inhibitor rescue therapy due to stent thrombosis, combined with persistent stent patency seen on angiographic imaging at 24-36 hours, and 2) have no sICH. sICH is defined as parenchymal haemorrhage type 2 (PH2) on imaging.
Query!
Timepoint [1]
0
0
24-36 hours
Query!
Secondary outcome [1]
0
0
Proportion of patients achieving reperfusion.
Query!
Assessment method [1]
0
0
The proportion of patients achieving reperfusion, where reperfusion is defined by the expanded Thrombolysis in Cerebral Infarction scale (eTICI) 2b50 or better (i.e. 50% to 100%)
Query!
Timepoint [1]
0
0
24 hours
Query!
Secondary outcome [2]
0
0
Infarct volume 24-36 hours post study drug commencement
Query!
Assessment method [2]
0
0
Query!
Timepoint [2]
0
0
24-36 hours
Query!
Secondary outcome [3]
0
0
Proportion of all patients with any ICH within 24-36 hours post study drug commencement
Query!
Assessment method [3]
0
0
All ICH as demonstrated on brain imaging at 24-36 hours, where ICH will be classified according to The Heidelberg Bleeding Classification.
Query!
Timepoint [3]
0
0
24-36 hours
Query!
Secondary outcome [4]
0
0
Proportion of patients experiencing any bleeding within 24-36 hours of study drug commencement.
Query!
Assessment method [4]
0
0
The proportion of patients experiencing any bleeding within 24-36 hours of study drug commencement. Bleeding will be determined using a modified WHO scale with grades 1 and 2 classified as minor bleeding, and grades 3 and 4 as major bleeding.
Query!
Timepoint [4]
0
0
24-36 hours
Query!
Secondary outcome [5]
0
0
National Institutes of Health Stroke Scale (NIHSS) at 24 hours, and 7 days/at hospital Discharge
Query!
Assessment method [5]
0
0
The National Institutes of Health Stroke Scale (NIHSS) is a 15-item neurological examination stroke scale. Scores range from 0 to 42, with higher scores indicating greater severity.
Query!
Timepoint [5]
0
0
24 hours and 7 days
Query!
Secondary outcome [6]
0
0
Modified Rankin Scale (mRS) score at discharge and 90 days
Query!
Assessment method [6]
0
0
The Modified Rankin Scale (mRS) is a scale from 0 to 6, with higher scores indicating greater disability (5), and death (6).
Query!
Timepoint [6]
0
0
90 days
Query!
Secondary outcome [7]
0
0
Proportion of patients with all-cause mortality at 90 days.
Query!
Assessment method [7]
0
0
Query!
Timepoint [7]
0
0
90 days
Query!
Eligibility
Key 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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key 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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people assessing the outcomes
Query!
Query!
Query!
Query!
Intervention assignment
Other
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Not yet recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
1/05/2025
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
31/12/2026
Query!
Actual
Query!
Sample size
Target
78
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW
Query!
Recruitment hospital [1]
0
0
John Hunter Hospital - Newcastle
Query!
Recruitment hospital [2]
0
0
Royal North Shore Hospital - St Leonards
Query!
Recruitment postcode(s) [1]
0
0
2305 - Newcastle
Query!
Recruitment postcode(s) [2]
0
0
2065 - St Leonards
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
ThromBio Pty. Ltd.
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
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). Patients with tandem occlusion undergoing EVT and acute stenting will receive intravenous TBO-309 bolus and infusion. TBO-309 is a potent, selective and ATP competitive PI3K\[beta\] inhibitor which reduces platelet activation adhesion/aggregation particularly under conditions of disturbed blood flow and promotes platelet disaggregation. By targeting PI3K\[beta\], TBO-309 specifically inhibits thrombosis whilst minimizing the impact on normal hemostasis.
Query!
Trial website
https://clinicaltrials.gov/study/NCT06813651
Query!
Trial related presentations / publications
Saver JL, Chaisinanunkul N, Campbell BCV, Grotta JC, Hill MD, Khatri P, Landen J, Lansberg MG, Venkatasubramanian C, Albers GW; XIth Stroke Treatment Academic Industry Roundtable. Standardized Nomenclature for Modified Rankin Scale Global Disability Outcomes: Consensus Recommendations From Stroke Therapy Academic Industry Roundtable XI. Stroke. 2021 Aug;52(9):3054-3062. doi: 10.1161/STROKEAHA.121.034480. Epub 2021 Jul 29. Miller AB, Hoogstraten B, Staquet M, Winkler A. Reporting results of cancer treatment. Cancer. 1981 Jan 1;47(1):207-14. doi: 10.1002/1097-0142(19810101)47:13.0.co;2-6. Heddle NM, Cook RJ, Tinmouth A, Kouroukis CT, Hervig T, Klapper E, Brandwein JM, Szczepiorkowski ZM, AuBuchon JP, Barty RL, Lee KA; SToP Study Investigators of the BEST Collaborative. A randomized controlled trial comparing standard- and low-dose strategies for transfusion of platelets (SToP) to patients with thrombocytopenia. Blood. 2009 Feb 12;113(7):1564-73. doi: 10.1182/blood-2008-09-178236. Epub 2008 Dec 24. von Kummer R, Broderick JP, Campbell BC, Demchuk A, Goyal M, Hill MD, Treurniet KM, Majoie CB, Marquering HA, Mazya MV, San Roman L, Saver JL, Strbian D, Whiteley W, Hacke W. The Heidelberg Bleeding Classification: Classification of Bleeding Events After Ischemic Stroke and Reperfusion Therapy. Stroke. 2015 Oct;46(10):2981-6. doi: 10.1161/STROKEAHA.115.010049. Epub 2015 Sep 1. No abstract available. Wahlgren N, Ahmed N, Davalos A, Ford GA, Grond M, Hacke W, Hennerici MG, Kaste M, Kuelkens S, Larrue V, Lees KR, Roine RO, Soinne L, Toni D, Vanhooren G; SITS-MOST investigators. Thrombolysis with alteplase for acute ischaemic stroke in the Safe Implementation of Thrombolysis in Stroke-Monitoring Study (SITS-MOST): an observational study. Lancet. 2007 Jan 27;369(9558):275-82. doi: 10.1016/S0140-6736(07)60149-4. Erratum In: Lancet. 2007 Mar 10;369(9564):826. Jackson SP, Schoenwaelder SM. Antithrombotic phosphoinositide 3-kinase beta inhibitors in humans: a 'shear' delight! J Thromb Haemost. 2012 Oct;10(10):2123-6. doi: 10.1111/j.1538-7836.2012.04912.x. No abstract available. Nylander S, Wagberg F, Andersson M, Skarby T, Gustafsson D. Exploration of efficacy and bleeding with combined phosphoinositide 3-kinase beta inhibition and aspirin in man. J Thromb Haemost. 2015 Aug;13(8):1494-502. doi: 10.1111/jth.13027. Epub 2015 Jul 23. Nylander S, Kull B, Bjorkman JA, Ulvinge JC, Oakes N, Emanuelsson BM, Andersson M, Skarby T, Inghardt T, Fjellstrom O, Gustafsson D. Human target validation of phosphoinositide 3-kinase (PI3K)beta: effects on platelets and insulin sensitivity, using AZD6482 a novel PI3Kbeta inhibitor. J Thromb Haemost. 2012 Oct;10(10):2127-36. doi: 10.1111/j.1538-7836.2012.04898.x. Jackson SP, Schoenwaelder SM, Goncalves I, Nesbitt WS, Yap CL, Wright CE, Kenche V, Anderson KE, Dopheide SM, Yuan Y, Sturgeon SA, Prabaharan H, Thompson PE, Smith GD, Shepherd PR, Daniele N, Kulkarni S, Abbott B, Saylik D, Jones C, Lu L, Giuliano S, Hughan SC, Angus JA, Robertson AD, Salem HH. PI 3-kinase p110beta: a new target for antithrombotic therapy. Nat Med. 2005 May;11(5):507-14. doi: 10.1038/nm1232. Epub 2005 Apr 17.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Ferdinand Miteff - Interventional Neurologist, RACP, CCINR
Query!
Address
0
0
John Hunter Hospital, Newcastle, NSW Australia
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Ferdinand Miteff - Interventional Neurologist, RACP, CCINR
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
612 4921 3490
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
Query!
No/undecided IPD sharing reason/comment
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06813651
Download to PDF