Actively Recruiting
Extending the Time Window for Tenecteplase by Recanalization of Basilar Artery Occlusion in Posterior Circulation Stroke
Led by University of Melbourne · Updated on 2026-05-06
688
Participants Needed
17
Research Sites
387 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Extending the Time Window for Tenecteplase by Recanalization of Basilar Artery Occlusion in Posterior Circulation Stroke
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients presenting with posterior circulation ischemic stroke symptoms due to partial or complete basilar artery occlusion within 24 hours from symptom onset or last known well time
- Age 18 years or older
- Basilar artery occlusion confirmed by CT Angiography or MR Angiography, considered potentially retrievable
- Premorbid modified Rankin Scale score of 3 or less
- Consent obtained according to local legal requirements
You will not qualify if you...
- Intracerebral hemorrhage or other diagnoses like tumor on baseline imaging
- Posterior circulation Acute Stroke Prognosis Early CT score (pc-ASPECTS) less than 7
- Significant cerebellar swelling or acute hydrocephalus
- Established subacute infarction visible on non-contrast CT
- Extensive bilateral brainstem ischemia
- Suspected underlying intracranial atherosclerotic disease or dissection requiring immediate neuro-intervention
- Premorbid modified Rankin Scale score of 4 or more
- Standard contraindications to intravenous thrombolysis
- Contraindications to imaging with contrast agents
- Clinically evident pregnancy
- Participation in another investigational drug study
- Known terminal illness with life expectancy under one year
- Planned withdrawal of care or comfort measures
- Any condition posing hazards or interfering with study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
Bankstown-Lidcombe Hospital
Bankstown, New South Wales, Australia
Not Yet Recruiting
2
John Hunter Hospital
Newcastle, New South Wales, Australia
Not Yet Recruiting
3
Liverpool Hospital
Sydney, New South Wales, Australia
Actively Recruiting
4
Gold Coast Hospital
Gold Coast, Queensland, Australia
Not Yet Recruiting
5
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Actively Recruiting
6
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Actively Recruiting
7
Alfred Health
Melbourne, Victoria, Australia
Actively Recruiting
8
Austin Hospital
Melbourne, Victoria, Australia
Actively Recruiting
9
Box Hill Hospital
Melbourne, Victoria, Australia
Actively Recruiting
10
Monash Health
Melbourne, Victoria, Australia
Not Yet Recruiting
11
Royal Melbourne Hospital
Melbourne, Victoria, Australia
Actively Recruiting
12
Western Health
Melbourne, Victoria, Australia
Actively Recruiting
13
Fiona Stanley Hospital
Murdoch, Western Australia, Australia, 6150
Actively Recruiting
14
Grampians Health
Ballarat, Australia
Actively Recruiting
15
Northern Hospital
Melbourne, Australia
Actively Recruiting
16
Hospital Geral de Fortaleza
Fortaleza, Brazil
Actively Recruiting
17
Tours University Hospital
Tours, France
Actively Recruiting
Research Team
F
Fana Alemseged, MD, PhD
CONTACT
E
Erin White
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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