Extending the Time Window for Tenecteplase by Recanalization of Basilar Artery Occlusion in Posterior Circulation Stroke
Recruiting
Phase 2Phase 3Interventional Study
Basilar Artery Occlusion
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
688 (estimated)
Sponsor
University of Melbourne · Other
Who this trial is looking for
This trial is looking for adult patients who have had a specific type of stroke caused by a blockage in the basilar artery. Participants will receive either standard care or a medication called tenecteplase before a procedure to remove the blockage.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have symptoms of a stroke due to a blockage in my basilar artery.
My stroke symptoms started within the last 24 hours.
I have a score of 3 or less on the modified Rankin Scale before my stroke.
You may not be able to join if
I have bleeding in my brain or a tumor shown in initial imaging.
I have a low CT score indicating severe stroke damage.
I have a significant mass in my brain or fluid build-up.
I have major damage to both sides of my brainstem.
I have a serious underlying condition that needs immediate treatment.
I have a history of serious disability before my stroke.
I am pregnant.
I have a terminal illness.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 trea…
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).
Trial Locations
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Eligibility 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
* Pre…
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.
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