NCT05105633RecruitingPhase 2/3
Extending the Time Window for Tenecteplase by Recanalization of Basilar Artery Occlusion in Posterior Circulation Stroke
Extending the Time Window for Tenecteplase by Effective RecanalizatioN of bAsilar Artery occLusion in Patients With POSTerior Circulation Stroke (POST-ETERNAL)
Source: ClinicalTrials.gov · Last updated 6 May 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 688 (estimated)
- First submitted
- 21 Oct 2021
- Start date
- 29 Nov 2021
- Primary completion date
- May 2028
- Lead sponsor
- University of Melbourne
- Diseases
- Stroke
- NCT number
- NCT05105633
- EU CT number
- 2024-513444-28-00
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 688
- From 29 Nov 2021 to the primary completion date, May 2028
- 31 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Pre-stroke mRS of ≥4 (indicating moderate to severe previous disability).
- Current participation in another research drug treatment protocol.
Other illness
- 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.
- 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.
- Known terminal illness such that the patients would not be expected to survive a year.
- 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.
Other
- Significant cerebellar mass effect or acute hydrocephalus.
- Established frank hypodensity on non-contrast CT indicating subacute infarction.
- Bilateral extensive brainstem ischemia.
- Other standard contraindications to intravenous thrombolysis.
- Contraindication to imaging with contrast agents.
- Clinically evident pregnant women.
- Planned withdrawal of care or comfort care measures.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (31)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal Adelaide Hospital Coordinator of this site? Confirm its status | Adelaide | Australia | Recruiting |
| Grampians Health Coordinator of this site? Confirm its status | Ballarat | Australia | Recruiting |
| Bankstown-Lidcombe Hospital Coordinator of this site? Confirm its status | Bankstown | Australia | Not yet recruiting |
| Gold Coast Hospital Coordinator of this site? Confirm its status | Gold Coast | Australia | Not yet recruiting |
| Monash Health Coordinator of this site? Confirm its status | Melbourne | Australia | Not yet recruiting |
| Western Health Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| Northern Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| Austin Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| Royal Melbourne Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| Box Hill Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| Alfred Health Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| Fiona Stanley Hospital Coordinator of this site? Confirm its status | Murdoch | Australia | Recruiting |
| John Hunter Hospital Coordinator of this site? Confirm its status | Newcastle | Australia | Not yet recruiting |
| Liverpool Hospital Coordinator of this site? Confirm its status | Sydney | Australia | Recruiting |
| Princess Alexandra Hospital Coordinator of this site? Confirm its status | Woolloongabba | Australia | Recruiting |
| Hospital Geral de Fortaleza Coordinator of this site? Confirm its status | Fortaleza | Brazil | Recruiting |
| Centre hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| Centre Hospitalier De Versailles Coordinator of this site? Confirm its status | Le Chesnay Rocquencourt | France | Recruiting |
| Centre Hospitalier Universitaire De Lille Coordinator of this site? Confirm its status | Lille Cedex | France | Recruiting |
| Centre Hospitalier Regional De Marseille Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| Centre Hospitalier Universitaire De Montpellier Coordinator of this site? Confirm its status | Montpellier Cedex 5 | France | Recruiting |
| CHRU de Nancy Coordinator of this site? Confirm its status | Nancy | France | Recruiting |
| Centre Hospitalier Universitaire D Orleans Coordinator of this site? Confirm its status | Orleans Cedex 2 | France | Recruiting |
| Fondation A. de Rothschild Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| GIE Groupe hospitalier Paris Saint-Joseph/Vinci Coordinator of this site? Confirm its status | Paris Cedex 14 | France | Recruiting |
| Centre Hospitalier De Perpignan Coordinator of this site? Confirm its status | Perpignan Cedex | France | Recruiting |
| Centre Hospitalier Universitaire Reims Coordinator of this site? Confirm its status | Reims Cedex | France | Recruiting |
| Centre Hospitalier Universitaire de Rennes Coordinator of this site? Confirm its status | Rennes | France | Recruiting |
| Centre Hospitalier Universitaire Rouen Coordinator of this site? Confirm its status | Rouen Cedex | France | Recruiting |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Saint-Herblain | France | Recruiting |
| Centre Hospitalier Regional Universitaire De Tours Coordinator of this site? Confirm its status | Tours Cedex 9 | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.