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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

Titles & IDs
Public title
Safety, Tolerability and Efficacy of Adjunctive TBO-309 in Reperfusion for Stroke with Tandem Occlusion
Scientific title
Safety, Tolerability and Efficacy of Adjunctive TBO-309 in Reperfusion for Stroke with Tandem Occlusion
Secondary ID [1] 0 0
Application No. 00039
Secondary ID [2] 0 0
Co-STARS
Universal Trial Number (UTN)
Trial acronym
Co-STARS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ischemic Stroke 0 0
Tandem Occlusion 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of patients achieving a composite outcome of efficacy and safety
Timepoint [1] 0 0
24-36 hours
Secondary outcome [1] 0 0
Proportion of patients achieving reperfusion.
Timepoint [1] 0 0
24 hours
Secondary outcome [2] 0 0
Infarct volume 24-36 hours post study drug commencement
Timepoint [2] 0 0
24-36 hours
Secondary outcome [3] 0 0
Proportion of all patients with any ICH within 24-36 hours post study drug commencement
Timepoint [3] 0 0
24-36 hours
Secondary outcome [4] 0 0
Proportion of patients experiencing any bleeding within 24-36 hours of study drug commencement.
Timepoint [4] 0 0
24-36 hours
Secondary outcome [5] 0 0
National Institutes of Health Stroke Scale (NIHSS) at 24 hours, and 7 days/at hospital Discharge
Timepoint [5] 0 0
24 hours and 7 days
Secondary outcome [6] 0 0
Modified Rankin Scale (mRS) score at discharge and 90 days
Timepoint [6] 0 0
90 days
Secondary outcome [7] 0 0
Proportion of patients with all-cause mortality at 90 days.
Timepoint [7] 0 0
90 days

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Other
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/03/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
78
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
John Hunter Hospital - Newcastle
Recruitment postcode(s) [1] 0 0
2305 - Newcastle

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ThromBio Pty. Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ferdinand Miteff - Interventional Neurologist, RACP, CCINR
Address 0 0
John Hunter Hospital, Newcastle, NSW Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Ferdinand Miteff - Interventional Neurologist, RACP, CCINR
Address 0 0
Country 0 0
Phone 0 0
612 4921 3490
Fax 0 0
Email 0 0
ferdi.miteff@health.nsw.gov.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


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