Brief Summary

Patients presenting to the emergency department with an acute ischemic stroke due to basilar artery occlusion within 24 hours of stroke onset will be assessed to determine their eligibility for randomization into the trial. If the patient gives informed consent they will be randomised 50:50 using a central computerised allocation process to either standard of care (no intravenous thrombolytic treatment or intravenous alteplase 0.9mg/kg) or tenecteplase 0.25mg/kg before undergoing mechanical thrombectomy as required at treating clinician's discretion. The trial is Multi-arm, Multi-stage, prospective, randomised, open-label, blinded endpoint (PROBE) design with seamless phase 2b/3 transition if the intermediate endpoint (recanalization without symptomatic intracerebral hemorrhage) is met in analysis of the first 202 patients. Adaptive sample size re-estimation (Mehta and Pocock) will be performed when 240 patients have completed 3 month follow-up (minimum sample size 320, maximum sample size 688).

Trial Health

On Track

Trial Health Score

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

Enrollment

688

participants targeted

Target at P75+ for phase_2

Timeline

36mo left

Started Nov 2021

Longer than P75 for phase_2

Geographic Reach

3 countries

17 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

7.4 years study duration

Study Progress60%

Nov 2021May 2029

First Submitted

Initial submission to the registry

October 21, 2021

Completed

13 days until next milestone

First Posted

Study publicly available on registry

November 3, 2021

Completed

26 days until next milestone

Study Start

First participant enrolled

November 29, 2021

Completed

6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

Expected

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2029

Last Updated

May 6, 2026

Status Verified

March 1, 2026

Enrollment Period

6.4 years

First QC Date

October 21, 2021

Last Update Submit

April 29, 2026

Conditions

Basilar Artery Occlusion

Keywords

ischemic strokebasilar artery occlusionStrokeTenecteplaseTissue Plasminogen ActivatorCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesFibrin Modulating AgentsMolecular Mechanisms of Pharmacological Action

Outcome Measures

Primary Outcomes (1)

Modified Rankin Scale (mRS) 0-1 or return to baseline mRS at 90 days
Modified Rankin Scale (mRS) 0-1 (no disability) or return to baseline mRS (if baseline premorbid mRS 2-3) at 90 days
90 days

Secondary Outcomes (9)

Modified Rankin Scale 0-2 or return to baseline mRS at 90 days
90 days
Modified Rankin Scale 0-3 or return to baseline mRS at 90 days
90 days
Ordinal analysis of the mRS at 90 days
90 days
Early clinical improvement
72 hours
Substantial reperfusion on initial digital subtraction angiography run prior to thrombectomy
Initial angiogram (day 0)
+4 more secondary outcomes

Other Outcomes (1)

Intermediate outcome (Stage 1): Partial or complete recanalization of the basilar artery without sICH
Initial angiogram (day 0)

Study Arms (2)

Intravenous tenecteplase (TNK)

EXPERIMENTAL

Patients will receive intravenous tenecteplase (0.25mg/kg, maximum 25mg, administered as a bolus over 5-10 seconds).

Drug: Tenecteplase

Standard Care (which may include intravenous Alteplase)

ACTIVE COMPARATOR

Patients will receive standard of care (no intravenous thrombolytic treatment or intravenous alteplase 0.9mg/kg at the standard licensed dose of 0.9 mg/kg up to a maximum of 90mg, 10% as a bolus and the remainder as an infusion over 1 hour).

Drug: Standard Care (which may include intravenous Alteplase)

Interventions

TenecteplaseDRUG

Genetically modified tissue plasminogen activator at a dose of 0.25mg/kg given as an intravenous bolus over 5-10 seconds.

Intravenous tenecteplase (TNK)

Standard Care (which may include intravenous Alteplase)DRUG

Patients will receive standard care which may include intravenous alteplase at the standard licensed dose of 0.9 mg/kg up to a maximum of 90mg, 10% as a bolus and the remainder as an infusion over 1 hour.

Standard Care (which may include intravenous Alteplase)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients presenting with posterior circulation ischemic stroke symptoms due to partial or complete basilar artery occlusion within 24 hours from symptom onset (or clinical deterioration/coma) or the time the patient was last known to be well.
Patient's age is ≥18 years
Presence of basilar artery occlusion, proven by CT Angiography or MR Angiography. Basilar artery occlusion is defined as 'potentially retrievable' occlusion at the basilar artery. This can be a partial or complete occlusion.
Premorbid mRS ≤3 (independent function or requiring only minor domestic assistance and able to manage alone for at least 1 week).
Local legal requirements for consent have been satisfied.

You may not qualify if:

Intracerebral hemorrhage (ICH) or other diagnosis (e.g. tumour) identified by baseline imaging.
Posterior circulation Acute Stroke Prognosis Early CT score (pc-ASPECTS) \<7 on non-contrast CT, CT Angiography source images or DWI MRI.
Significant cerebellar mass effect or acute hydrocephalus.
Established frank hypodensity on non-contrast CT indicating subacute infarction.
Bilateral extensive brainstem ischemia.
Strong suspicion of underlying intracranial atherosclerotic disease (e.g diffuse arterial calcifications, basilar stenosis) or dissection which may require immediate neuro-interventional procedure with intracranial stenting and not benefit from intravenous thrombolysis at investigator's discretion.
Pre-stroke mRS of ≥4 (indicating moderate to severe previous disability).
Other standard contraindications to intravenous thrombolysis.
Contraindication to imaging with contrast agents.
Clinically evident pregnant women.
Current participation in another research drug treatment protocol.
Known terminal illness such that the patients would not be expected to survive a year.
Planned withdrawal of care or comfort care measures.
Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

University of Melbournelead

Study Sites (17)

Bankstown-Lidcombe Hospital

Bankstown, New South Wales, Australia

NOT YET RECRUITING

John Hunter Hospital

Newcastle, New South Wales, Australia

NOT YET RECRUITING

Liverpool Hospital

Sydney, New South Wales, Australia

RECRUITING

Gold Coast Hospital

Gold Coast, Queensland, Australia

NOT YET RECRUITING

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

RECRUITING

Royal Adelaide Hospital

Adelaide, South Australia, Australia

RECRUITING

Alfred Health