NCT04454788

Extending the Time Window for Tenecteplase by Effective Reperfusion in Patients with Large Vessel Occlusion

Extending the Time Window for Tenecteplase by Effective Reperfusion of PeNumbrAL Tissue in Patients with Large Vessel Occlusion

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 242 (actual)
• Sponsor: University of Melbourne · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients presenting to the emergency department with an acute ischemic stroke due to a large vessel occlusion eligible for thrombectomy and target mismatch on computed tomography perfusion imaging within 24 hours of onset will be assessed determine their eligibility for randomization into the trial. If the patient gives informed consent they will be randomised using a central computerised allocation process to either standard of care (no intravenous thrombolytic treatment or intravenous alteplase 0.9mg/kg) or tenecteplase before undergoing intra-arterial clot retrieval. The trial is prospective, randomised, open-label, blinded endpoint (PROBE) design.

Conditions

• Ischemic Stroke

Interventions

Type	Name	Description
DRUG	Tenecteplase	Genetically modified tissue plasminogen activator at a dose of 0.25mg/kg given as 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 bolus and the remainder over 1 hour.

Timeline

• Start date: 2020-08-01
• Primary completion: 2024-07-28
• Completion: 2025-01-06
• First posted: 2020-07-02
• Last updated: 2025-01-15

Locations

7 sites across 1 country: Australia