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Clinical Trials in France / NCT05105633
Recruiting Phase 2/3

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

NCT05105633 · tracked via the Priya Life Science France tracker
Phase
Phase 2/3
Started
2021-11-29
Last updated
2026-05-06

Condition(s) studied

Basilar Artery Occlusion

Investigational drug(s) / intervention(s)

Tenecteplase →Standard Care (which may include intravenous Alteplase)

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.

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (17)

FacilityCityRegionStatus
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

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Official registry record

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