Extending treatment options for stroke caused by basilar artery blockage
Extending the Time Window for Tenecteplase by Effective RecanalizatioN of bAsilar Artery occLusion in Patients With POSTerior Circulation Stroke (POST-ETERNAL)
This study is testing if a new treatment called tenecteplase can help people who have had a stroke from a blocked basilar artery feel better and recover more effectively compared to standard care.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 688 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Melbourne Academic / other |
| Locations | 17 sites (Bankstown, New South Wales and 16 other locations) |
| Trial ID | NCT05105633 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of tenecteplase, a thrombolytic agent, in patients experiencing acute ischemic stroke due to basilar artery occlusion. Patients will be randomly assigned to receive either standard care or tenecteplase before undergoing mechanical thrombectomy if necessary. The study employs a Multi-Arm Multi-Stage design with adaptive sample size adjustments based on interim results, focusing on recanalization rates and functional outcomes at three months. The trial aims to determine if extending the treatment window for tenecteplase can improve patient outcomes in this critical condition.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older presenting with posterior circulation ischemic stroke symptoms due to basilar artery occlusion within 24 hours of symptom onset.
Not a fit: Patients with intracerebral hemorrhage or significant pre-existing conditions that would preclude safe participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option that improves recovery outcomes for patients with basilar artery occlusion.
How similar studies have performed: While the use of tenecteplase in other stroke contexts has shown promise, this specific approach for basilar artery occlusion is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
Bankstown, New South Wales and 16 other locations
- 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, Australia (Recruiting)
- Royal Adelaide Hospital — Adelaide, South Australia, Australia (Recruiting)
- Alfred Health — Melbourne, Victoria, Australia (Recruiting)
- Austin Hospital — Melbourne, Victoria, Australia (Recruiting)
- Box Hill Hospital — Melbourne, Victoria, Australia (Recruiting)
- Monash Health — Melbourne, Victoria, Australia (Not_yet_recruiting)
- Royal Melbourne Hospital — Melbourne, Victoria, Australia (Recruiting)
- Western Health — Melbourne, Victoria, Australia (Recruiting)
- Fiona Stanley Hospital — Murdoch, Western Australia, Australia (Recruiting)
- Grampians Health — Ballarat, Australia (Recruiting)
- Northern Hospital — Melbourne, Australia (Recruiting)
- Hospital Geral de Fortaleza — Fortaleza, Brazil (Recruiting)
- Tours University Hospital — Tours, France (Recruiting)
Study contacts
- Principal investigator: Bruce Campbell — University of Melbourne
- Study coordinator: Fana Alemseged, MD, PhD
- Email: Fana.Alemseged@unimelb.edu.au
- Phone: +6193424424
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.