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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05363397




Registration number
NCT05363397
Ethics application status
Date submitted
2/05/2022
Date registered
5/05/2022
Date last updated
29/11/2023

Titles & IDs
Public title
Safety and Tolerability of Adjunctive TBO-309 in Reperfusion for Stroke
Scientific title
Safety and Tolerability of Adjunctive TBO-309 in Reperfusion for Stroke
Secondary ID [1] 0 0
U1111-1270-5195
Secondary ID [2] 0 0
CCD78277
Universal Trial Number (UTN)
Trial acronym
STARS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Ischemic Stroke 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

Experimental: TBO-309 30mg (25% of target dose) - Following randomisation, 30mg TBO-309 will be administered at the same time as the rt-PA infusion or tenecteplase bolus (as part of intravenous thrombolysis) or as soon as practical.
The allocated dose of TBO-309 will be given intravenously 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
Only one dose will be administered to the patient.

Experimental: TBO-309 60mg (50% of target dose) - Following randomisation, 60mg TBO-309 will be administered at the same time as the rt-PA infusion or tenecteplase bolus (as part of intravenous thrombolysis) or as soon as practical.
The allocated dose of TBO-309 will be given intravenously 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
Only one dose will be administered to the patient.

Experimental: TBO-309 120mg (100% of target dose) - Following randomisation, 120mg TBO-309 will be administered at the same time as the rt-PA infusion or tenecteplase bolus (as part of intravenous thrombolysis) or as soon as practical.
The allocated dose of TBO-309 will be given intravenously 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
Only one dose will be administered to the patient.

Experimental: TBO-309 180mg (150% of target dose) - Following randomisation, 180mg TBO-309 will be administered at the same time as the rt-PA infusion or tenecteplase bolus (as part of intravenous thrombolysis) or as soon as practical.
The allocated dose of TBO-309 will be given intravenously 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
Only one dose will be administered to the patient.


Treatment: Drugs: TBO-309
TBO-309 is a potent, selective and ATP competitive PI3Kß inhibitor which blocks platelet activation adhesion/aggregation and promotes platelet disaggregation, thereby specifically inhibiting thrombosis without interfering with normal haemostasis.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of patients with intracerebral hemorrhage (ICH)
Timepoint [1] 0 0
Within 24-36 hours of initiation of study drug
Secondary outcome [1] 0 0
All bleeding
Timepoint [1] 0 0
Within 72 hours of study drug administration
Secondary outcome [2] 0 0
All intracerebral hemorrhage (ICH)
Timepoint [2] 0 0
Up to 90 days post study drug administration
Secondary outcome [3] 0 0
All bleeding
Timepoint [3] 0 0
Up to 90 days post study drug administration

Eligibility
Key inclusion criteria
Inclusion Criteria

1. Patient aged 18 years or more

2. Patient has an acute ischaemic stroke (AIS)

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 LVO in the internal carotid artery, proximal
middle cerebral artery (M1 segment), proximal M2 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 (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
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

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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/09/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2025
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Timothy Ang - Camperdown
Recruitment hospital [2] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 0 0
John Hunter Hospital - New Lambton Heights
Recruitment hospital [4] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [5] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [6] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [4] 0 0
2031 - Randwick
Recruitment postcode(s) [5] 0 0
5000 - Adelaide
Recruitment postcode(s) [6] 0 0
3050 - Parkville

Funding & Sponsors
Primary sponsor type
Other
Name
The George Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Heart Research Institute
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05363397
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Candice Delcourt, Dr
Address 0 0
The George Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Candice Delcourt, Dr
Address 0 0
Country 0 0
Phone 0 0
+61 2 8052 4601
Fax 0 0
Email 0 0
cdelcourt@georgeinstitute.org.au
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05363397