RecruitingPhase 2Phase 3NCT05892510

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)

Sponsor

University of Melbourne

Enrollment

462 participants

Start Date

Jun 1, 2024

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Intra-arterial tenecteplase injection at the completion of thrombectomy and a drug called Placebo for people with brain disorder, central nervous system diseases, and other related conditions. The study is currently recruiting participants at 12 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGIntra-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

DRUGPlacebo

intra-arterial bolus of 0.9% Sodium Chloride solution

Locations(12)

Gold Coast Univeristy Hospital

Gold Coast, Queensland, Australia

Royal Adelaide Hospital

Adelaide, Australia

Alfred Hospital

Melbourne, Australia

Austin Hospital

Melbourne, Australia

Monash Medical Centre

Melbourne, Australia

Royal Melbourne Hospital

Melbourne, Australia

Fiona Stanley Hospital

Perth, Australia

Sir Charles Gairdner Hospital

Perth, Australia

Liverpool Hospital

Sydney, Australia

Royal North Shore Hospital

Sydney, Australia

Townsville University Hospital

Townsville, Australia

Christchurch Hospital

Christchurch, New Zealand

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05892510

Related Trials

Single Bolus Non-immunogenic Staphylokinase in Patients With Acute Ischemic Stroke Within 4.5-24 Hours of Symptom Onset

NCT0732483722 locations

Study of Silevertinib With Temozolomide for the Treatment of Newly Diagnosed GBM With Unmethylated MGMT and EGFRvIII

NCT0732656622 locations

Tegoprazan for Prevention of Gastrointestinal Complication in Ischemic Stroke Patients on Antiplatelet Therapy (TegoStroke)

NCT0768770624 locations

Third Enhanced Control of Hypertension and Thrombectomy Stroke Domain Within ACT-GLOBAL Adaptive Platform Trial

NCT063526192 locations

Combined Analysis of Inflammatory Biomarkers for CNS Autoimmune Diseases Diagnostic

NCT050567401 location