Tenecteplase: Genetically modified tissue plasminogen activator at a dose of 0.25mg/kg given as an intravenous bolus over 5-10 seconds.
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.
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).
| Facility | City | Region | Status |
|---|---|---|---|
| Bankstown-Lidcombe Hospital | Bankstown | New South Wales | Not Yet Recruiting |
| John Hunter Hospital | Newcastle | New South Wales | Not Yet Recruiting |
| Liverpool Hospital | Sydney | New South Wales | Recruiting |
| Gold Coast Hospital | Gold Coast | Queensland | Not Yet Recruiting |
| Princess Alexandra Hospital | Woolloongabba | Queensland | Recruiting |
| Royal Adelaide Hospital | Adelaide | South Australia | Recruiting |
| Alfred Health | Melbourne | Victoria | Recruiting |
| Austin Hospital | Melbourne | Victoria | Recruiting |
| Box Hill Hospital | Melbourne | Victoria | Recruiting |
| Monash Health | Melbourne | Victoria | Not Yet Recruiting |
| Royal Melbourne Hospital | Melbourne | Victoria | Recruiting |
| Western Health | Melbourne | Victoria | Recruiting |
| Fiona Stanley Hospital | Murdoch | Western Australia | Recruiting |
| Grampians Health | Ballarat | Australia | Recruiting |
| Northern Hospital | Melbourne | Australia | Recruiting |
| Hospital Geral de Fortaleza | Fortaleza | Brazil | Recruiting |
| Tours University Hospital | Tours | France | Recruiting |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05105633 on ClinicalTrials.gov ↗ ← All trials in France