NCT05892510

Post-thrombectomy Intra-arterial Tenecteplase for Acute manaGement of Non-retrievable Thrombus and No-reflow in Emergent Stroke

Post-thrombectomy Intra-arterial Tenecteplase for Acute manaGement of Non-retrievable Thrombus and No-reflow in Emergent Stroke (EXTEND-AGNES TNK)

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 462 (estimated)
• Sponsor: University of Melbourne · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Multicentre, prospective, Multi-arm Multi-stage (MAMS) seamless phase 2b/3 interventional randomized placebo-controlled double-blinded parallel-assignment (2 arms with 1:1 randomization) efficacy and safety trial to test intra-arterial tenecteplase at the completion of thrombectomy versus best practice in participants with anterior circulation LVO receiving mechanical thrombectomy within 24 hours of symptoms onset.

Conditions

• Ischemic Stroke, Acute
• Cerebrovascular Disorders
• Brain Disorder
• Central Nervous System Diseases

Interventions

Type	Name	Description
DRUG	Intra-arterial tenecteplase injection at the completion of thrombectomy	Intra-arterial tenecteplase (0.062mg/kg, maximum 6.25mg) administered as a bolus at the completion of thrombectomy through a microcatheter at the site of the initial-but-now-retrieved intracranial occlusion, or in direct contact with the residual thrombus
DRUG	Placebo	intra-arterial bolus of 0.9% Sodium Chloride solution

Timeline

• Start date: 2024-06-01
• Primary completion: 2027-08-30
• Completion: 2027-11-30
• First posted: 2023-06-07
• Last updated: 2025-07-25

Locations

13 sites across 1 country: Australia