Extending the Time Window for Tenecteplase by Recanalization of Basilar Artery Occlusion in Posterior Circulation Stroke

Recruiting now · Phase 2/Phase 3

Conditions studied: Basilar Artery Occlusion

In brief

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).

Key facts

Study ID

NCT05105633

Run by

University of Melbourne

People needed

688

Starts

2021-11-29

Expected to finish

2029-05-01

Last updated by the study team

2026-05-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Tours University Hospital — Tours, France (enrolling)
• Fiona Stanley Hospital — Murdoch, Western Australia, Australia (enrolling)
• Grampians Health — Ballarat, Australia (enrolling)
• Northern Hospital — Melbourne, Australia (enrolling)
• Hospital Geral de Fortaleza — Fortaleza, Brazil (enrolling)
• Liverpool Hospital — Sydney, New South Wales, Australia (enrolling)
• Princess Alexandra Hospital — Woolloongabba, Queensland, Australia (enrolling)
• Royal Adelaide Hospital — Adelaide, South Australia, Australia (enrolling)
• Alfred Health — Melbourne, Victoria, Australia (enrolling)
• Austin Hospital — Melbourne, Victoria, Australia (enrolling)
• Box Hill Hospital — Melbourne, Victoria, Australia (enrolling)
• Royal Melbourne Hospital — Melbourne, Victoria, Australia (enrolling)
• Western Health — Melbourne, Victoria, Australia (enrolling)
• John Hunter Hospital — Newcastle, New South Wales, Australia
• Monash Health — Melbourne, Victoria, Australia
• Gold Coast Hospital — Gold Coast, Queensland, Australia
• Bankstown-Lidcombe Hospital — Bankstown, New South Wales, Australia

Full record on ClinicalTrials.gov

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