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Post-thrombectomy Intra-arterial Tenecteplase for Acute manaGement of Non-retrievable Thrombus and No-reflow in Emergent Stroke
Sponsor: University of Melbourne
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
Conditions
Interventions
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
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