NCT05363397

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 Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 5, 2022

Completed
1.4 years until next milestone

Study Start

First participant enrolled

September 27, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

December 1, 2025

Status Verified

November 1, 2025

Enrollment Period

2.4 years

First QC Date

May 2, 2022

Last Update Submit

November 24, 2025

Conditions

Acute Ischemic Stroke

Keywords

Antiplatelet therapyStrokeBlood clotIntravenous thrombolysis (IVT)Endovascular Thrombectomy (EVT)TBO-309

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with ICH within 24-36 hours of study drug (TBO-309) commencement.

    Proportion of patients with ICH within 24-36 hours of study drug (TBO-309) commencement. ICH is defined as parenchymal haemorrhage (PH) type II based on The Heidelberg Bleeding Classification or any intracranial haemorrhage leading to clinical deterioration i.e. an increase in NIHSS of 4 points or more, on post-intervention brain MRI with MRA or multimodal CT scan (see appendix 2 and 3). This definition allows the inclusion of any clinically and radiologically significant haemorrhage with the rate of expected ICH in this patient population estimated to be up to 8%

    Within 24-36 hours of initiation of study drug

Secondary Outcomes (4)

  • All bleeding

    Within 72 hours of study drug administration

  • All ICH

    24-36 hours

  • All intracerebral hemorrhage (ICH)

    Up to 90 days post study drug administration

  • All bleeding

    Up to 90 days post study drug administration

Other Outcomes (10)

  • Recanalisation rate

    Within 2-6 hours of study drug commencement

  • Reperfusion rates

    Post EVT

  • Infarct volume

    24-36 hours post study drug commencement

  • +7 more other outcomes

Study Arms (4)

TBO-309 30mg (25% of target dose)

EXPERIMENTAL

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.

Drug: TBO-309

TBO-309 60mg (50% of target dose)

EXPERIMENTAL

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.

Drug: TBO-309

TBO-309 120mg (100% of target dose)

EXPERIMENTAL

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.

Drug: TBO-309

TBO-309 180mg (150% of target dose)

EXPERIMENTAL

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.

Drug: TBO-309

Interventions

TBO-309DRUG

TBO-309 is a potent, selective and ATP competitive PI3Kβ inhibitor which blocks platelet activation adhesion/aggregation and promotes platelet disaggregation, thereby specifically inhibiting thrombosis without interfering with normal haemostasis.

TBO-309 120mg (100% of target dose)TBO-309 180mg (150% of target dose)TBO-309 30mg (25% of target dose)TBO-309 60mg (50% of target dose)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient aged 18 years or more
  • Patient has an acute ischaemic stroke
  • Patient will be treated with either:
  • Intravenous thrombolysis (IVT) with alteplase or tenecteplase for a diagnosis of AIS that is confirmed by CT imaging;
  • alone/OR WITH
  • Endovascular Thrombectomy (EVT) for large vessel occlusion (LVO) in the internal carotid artery, middle cerebral artery (M1 segment), middle cerebral artery (M2 segment) or with tandem occlusion of both the cervical carotid and intracranial large arteries who either:
  • i. presented within 6 hours of stroke onset
  • 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.
  • Patient has at least a mild grade of neurological impairment i.e. NIHSS of 5 or more
  • Patient has an estimated pre-stroke mRS of less than 4

You may not qualify 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 MCA territory
  • High likelihood of undergoing stent insertion and requiring additional antithrombotic(s)
  • Uncontrolled hypertension (SBP \>180 or DBP \>110, refractory to medical therapy)
  • ICH 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
  • Contraindication to thrombolysis i.e. increased bleeding risk
  • Contraindication to intravenous contrast agents including renal impairment or allergy
  • Known treatment with dual antiplatelet therapy or anticoagulant medication
  • Known severe liver disease
  • Known bleeding disorder
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

RECRUITING

Liverpool Hospital

Liverpool, New South Wales, 2170, Australia

RECRUITING

John Hunter Hospital

New Lambton Heights, New South Wales, 2305, Australia

RECRUITING

Prince of Wales Hospital

Randwick, New South Wales, 2031, Australia

RECRUITING

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

RECRUITING

Eastern Health- Box Hill Hospital

Box Hill, Victoria, 3128, Australia

RECRUITING

Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

RECRUITING

MeSH Terms

Conditions

Ischemic StrokeStrokeThrombosis

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesEmbolism and Thrombosis

Study Officials

  • Candice Delcourt, Dr

    The George Institute

    STUDY CHAIR

Central Study Contacts

Candice Delcourt, Dr

CONTACT

+61 2 8052 4601cdelcourt@georgeinstitute.org.au

Michele Sallaberger

CONTACT

+61 438471423michele.sallaberger@florey.edu.au

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Independent imaging assessors will review and adjudicate blinded study data to ensure the primary endpoint meets consistent pre-determined diagnostic criteria. This will include centralised review of de-identified CT and MRI/MRA images. Members will be qualified physicians who are independent of the study and not involved in study management.
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Continual Reassessment Method
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2022

First Posted

May 5, 2022

Study Start

September 27, 2023

Primary Completion

February 1, 2026

Study Completion

May 1, 2026

Last Updated

December 1, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

AU(7)