Basilar Artery OcclusionPhase 2/3POST-ETERNALNCT05105633
Extending the Time Window for Tenecteplase by Recanalization of Basilar Artery Occlusion in Posterior Circulation Stroke
A Phase 2/3 study testing Tenecteplase in people with Basilar Artery Occlusion, run by University of Melbourne at 17 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Basilar Artery Occlusion
- What is being tested?
- Tenecteplase
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 688 participants
- Where
- 17 sitesin 3 countries
- Study dates
- 29 Nov 2021to May 2029
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
17 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
Erin White contact
17 sites in 3 countries
Australia15 sites, 15 recruiting
- Recruiting
Royal Adelaide Hospital
Adelaide, South Australia
Jennifer Cranefield
Timothy Kleinig
- Recruiting
Grampians Health
Ballarat
Melbin Samuvel, +61(03) 53305104, Melbin.Samuvel@gh.org.au
- Not yet recruiting
Bankstown-Lidcombe Hospital
Bankstown, New South Wales
Megan Miller
Fintan O' Rourke
- Not yet recruiting
Gold Coast Hospital
Gold Coast, Queensland
Berzenn Urbi
Peter Bailey
- Recruiting
Alfred Health
Melbourne, Victoria
Andrea Moore
Geoffrey Cloud
- Recruiting
Austin Hospital
Melbourne, Victoria
Joanne Dimovitis, joanne.dimovitis@austin.org.au
Vincent Thijs
- Recruiting
Box Hill Hospital
Melbourne, Victoria
Tessa Busch
Philip Choi
- Not yet recruiting
Monash Health
Melbourne, Victoria
Marie Veronic Hervet
Shaloo Singhal
- Recruiting
Royal Melbourne Hospital
Melbourne, Victoria
Amy McDonald, BN, +619342 4424, amy.mcdonald@mh.org.au
Bruce Campbell
- Recruiting
Western Health
Melbourne, Victoria
Sherisse Celestino
Tissa Wijeratne
- Recruiting
Northern Hospital
Melbourne
Douglas Crompton, +61(03) 8405 8000
- Recruiting
Fiona Stanley Hospital
Murdoch, Western Australia, 6150
Phoebe Lee
Darshan Ghia
- Not yet recruiting
John Hunter Hospital
Newcastle, New South Wales
Michelle Russell
Carlos Garcia Esperon
- Recruiting
Liverpool Hospital
Sydney, New South Wales
Timmy Pham, timmy.pham@health.nsw.gov.au
Dennis Cordato
- Recruiting
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
Carol Bendall
Michael Devlin
Brazil1 site, 1 recruiting
- Recruiting
Hospital Geral de Fortaleza
Fortaleza
Maria Samara Souza, +55 (85) 991969752, mariasamarasouza32@gmail.com
Francisco Mont'Alverne
France1 site, 1 recruiting
- Recruiting
Tours University Hospital
Tours
Yoann DESVIGNES, +33247474632, y.desvignes@chu-tours.fr
Marco Pasi
About this study
Official title: Extending the Time Window for Tenecteplase by Effective RecanalizatioN of bAsilar Artery occLusion in Patients With POSTerior Circulation Stroke (POST-ETERNAL)
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).
Read the detailed description
The study is a Multi-Arm Multi-Stage (MAMS), multiregional, multicentre, prospective, randomised, open-label, blinded endpoint (PROBE), controlled seamless phase 2b/3 trial (2 arm with 1:1 randomisation) with adaptive sample size recalculation in patients with stroke due to basilar artery occlusion. Stage 1 will use the surrogate outcome of recanalization without symptomatic intracerebral hemorrhage (sICH) to establish whether proceeding to Stage 2 is warranted. If results in the first n= 202 patients meet success criteria, the trial will seamlessly convert to a phase 3 design using modified Rankin scale 0-1 at 3 months as the primary outcome (minimum n=320 with interim sample size re-estimation at n=240, maximum sample n=688) using the Mehta and Pocock conditional power method. Each regionally-based stratum will be pooled in the final analysis and analysed as a stratification by geographic region. Randomisation of patients within each stratum will be stratified by the investigator's intention to treat with mechanical thrombectomy (or not) and the investigator's intention to treat with alteplase intravenous thrombolysis should the patient be randomised to the control group (or not). Covariate adjusted minimum sufficient balance randomisation will then be applied to control for age, NIHSS and time from onset-to-randomisation (dichotomized as 0-6 hours vs 6-24 hours). The primary objective of the study is to test the hypothesis that the thrombolytic tenecteplase (TNK, 0.25mg/kg) ± mechanical thrombectomy administered within 24 hours after symptoms onset, is superior to current best practice (alteplase, rtPA, 0.9mg/kg or standard care/no lysis ± mechanical thrombectomy) in achieving excellent functional outcome (mRS 0-1) or return to the premorbid modified Rankin Scale at 90 days in patients with acute ischemic stroke due to basilar artery occlusion. Estimated study duration is 5 years. Patients will participate in the trial for 12 months.
- Conditions
- Basilar Artery Occlusion
- Being tested
- Tenecteplase, Standard Care (which may include intravenous Alteplase)
- Keywords
- ischemic stroke, basilar artery occlusion, Stroke, Tenecteplase, Tissue Plasminogen Activator, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Vascular Diseases, Cardiovascular Diseases, Fibrin Modulating Agents, Molecular Mechanisms of Pharmacological Action
- Medical subject headings
- Ischemic Stroke, Stroke, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Vascular Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TenecteplaseDrug
Genetically modified tissue plasminogen activator at a dose of 0.25mg/kg given as an intravenous bolus over 5-10 seconds.
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.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous tenecteplase (TNK) | Experimental | Patients will receive intravenous tenecteplase (0.25mg/kg, maximum 25mg, administered as a bolus over 5-10 seconds). Receives: 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). Receives: Drug: Standard Care (which may include intravenous Alteplase) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 90 days
Secondary outcomes (9)
Modified Rankin Scale 0-2 or return to baseline mRS at 90 days
Proportion of patients with Modified Rankin Scale 0-2 or return to baseline mRS at 90 days
Measured: 90 days
Modified Rankin Scale 0-3 or return to baseline mRS at 90 days
Proportion of patients with Modified Rankin Scale 0-3 or return to baseline mRS at 90 days
Measured: 90 days
Ordinal analysis of the mRS at 90 days
Ordinal analysis of the mRS, merging category 5-6, at 90 days
Measured: 90 days
Early clinical improvement
Proportion of patients achieving early clinical improvement (reduction in acute - 72 hour NIHSS score of ≥8 or 72 hour NIHSS 0-1).
Measured: 72 hours
Substantial reperfusion on initial digital subtraction angiography run prior to thrombectomy
Proportion of patients with complete occlusion at baseline who achieve eTICI 2b/3 on initial digital subtraction angiography run prior to thrombectomy.
Measured: Initial angiogram (day 0)
Quality of Life assessment (EQ-5D) - at 90 days and 12 months
Quality of Life assessment (EQ-5D) - at 90 days and 12 months
Measured: 90 days and 12 months
Symptomatic intracerebral hemorrhage (sICH)
Proportion of patients with sICH defined as parenchymal hemorrhage type 2 (PH2), subarachnoid hemorrhage, and/or intraventricular hemorrhage within 36 of treatment, combined with a neurological deterioration of ≥4 points on the NIHSS from baseline, or leading to death.
Measured: 36 hours
All-cause mortality within 90 days
All-cause mortality within 90 days
Measured: 90 days
Modified Rankin Scale (mRS) 5-6 at 90 days
Proportion of patients with Modified Rankin Scale (mRS) 5-6 at 90 days (severe disability or death)
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start29 Nov 2021
- Primary completionMay 2028 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Basilar Artery OcclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will receive either intravenous tenecteplase (0.25mg/kg, maximum 25mg, administered as a bolus over 5-10 seconds) or standard of care (alteplase 0.9mg/kg or no lysis) +/- mechanical thrombectomy
- Masking
- None (open label)
- Enrolment
- 688 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Melbourne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruce Campbell, Principal investigator, University of MelbourneFana Alemseged, Principal investigator, University of Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05105633
- Sponsor's protocol ID
- CT21028
- Acronym
- POST-ETERNAL
- Status last verified
- Mar 2026
- First submitted
- 21 Oct 2021
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual patient data will be uploaded to the Virtual Stroke Trials Archive 2 years after the publication of the primary manuscript. Qualified investigators can access data after submission of a project proposal that has been approved by the VISTA steering committee.