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RECRUITINGPhase 2 / Phase 3INTERVENTIONAL

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)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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).

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Should NOT Join This Trial: - 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Tenecteplase

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

DRUG

Standard Care (which may include intravenous Alteplase)

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.

Locations (13)

Bankstown-Lidcombe Hospital
Bankstown, New South Wales, Australia
John Hunter Hospital
Newcastle, New South Wales, Australia
Liverpool Hospital
Sydney, New South Wales, Australia
Gold Coast Hospital
Gold Coast, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Alfred Health
Melbourne, Victoria, Australia
Austin Hospital
Melbourne, Victoria, Australia
Box Hill Hospital
Melbourne, Victoria, Australia
Monash Health
Melbourne, Victoria, Australia
Royal Melbourne Hospital
Melbourne, Victoria, Australia
Western Health
Melbourne, Victoria, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia