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RECRUITING
NCT05892510
PHASE2/PHASE3

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

Sponsor: University of Melbourne

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

462

Start Date

2024-06-01

Completion Date

2027-11-30

Last Updated

2025-07-25

Healthy Volunteers

No

Interventions

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

Locations (13)

Gold Coast Univeristy Hospital

Gold Coast, Queensland, Australia

Royal Adelaide Hospital

Adelaide, Australia

Princess Alexandra Hospital

Brisbane, Australia

Royal Brisbane and Women's Hospital

Brisbane, Australia

Canberra Hospital

Canberra, Australia

Alfred Hospital

Melbourne, Australia

Austin Hospital

Melbourne, Australia

Monash Medical Centre

Melbourne, Australia

Royal Melbourne Hospital

Melbourne, Australia

John Hunter Hospital

Newcastle, Australia

Fiona Stanley Hospital

Perth, Australia

Liverpool Hospital

Sydney, Australia

Royal North Shore Hospital

Sydney, Australia