Actively Recruiting
Post-thrombectomy Intra-arterial Tenecteplase for Acute Management of Non-retrievable Thrombus and No-reflow in Emergent Stroke (EXTEND-AGNES TNK)
Led by University of Melbourne · Updated on 2026-05-18
462
Participants Needed
12
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of intra-arterial tenecteplase given at the end of mechanical thrombectomy in adults with acute ischemic stroke caused by a blockage in a large artery in the brain. This randomized, placebo-controlled trial compares tenecteplase to standard care with a saline placebo to study its safety and effectiveness within 24 hours of stroke symptom onset. The study is a phase 2b/3 trial designed to test early neurological improvement and longer-term functional independence in participants. Participants receive either an intra-arterial bolus of tenecteplase dosed by weight (maximum 6.25 mg) or a placebo saline bolus administered directly at the site of the original artery blockage after thrombectomy. The trial includes two groups with equal chance of assignment and uses a double-blind design. The intervention occurs immediately after thrombectomy, targeting residual clots that may cause ongoing blood flow issues. During the study, participants are monitored for neurological improvement within 24 to 36 hours and functional independence at three months. Additional assessments include brain imaging to measure infarct growth and no-reflow, safety monitoring for bleeding events, mortality rates, and quality of life evaluation. The trial lasts at least three months from randomization, with multiple visits and tests to track outcomes and side effects.
CONDITIONS
Brief Title
Post-thrombectomy Intra-arterial Tenecteplase for Acute manaGement of Non-retrievable Thrombus and No-reflow in Emergent Stroke
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult participants aged 18 years or older
- Ischemic stroke with arterial large vessel occlusion in the intracranial internal carotid or middle cerebral artery (M1 or proximal M2)
- Eligible for mechanical thrombectomy within 24 hours of symptom onset
- For 0-6 hours from symptom onset: arterial occlusion and ASPECTS score of 3 or higher on non-contrast CT
- For 6-24 hours from symptom onset: additional imaging criteria with core volume less than 100 ml on CT perfusion or MRI perfusion
- Qualifying CT or MR imaging within 4 hours before randomization
- Pre-stroke Modified Rankin Scale score of 2 or less (mild pre-existing disability allowed)
- Local legal requirements for informed consent are met
You will not qualify if you...
- Intracranial hemorrhage detected by CT or MRI
- ASPECTS score of 0 to 2 on non-contrast CT
- Core ischemic volume greater than 100 ml on CT perfusion or MRI if presenting 6-24 hours after symptom onset
- Planned endovascular stenting for intracranial or extracranial arterial narrowing or blockage
- More than six thrombectomy retrieval attempts in the same vessel
- Alteplase infusion within 30 minutes before planned trial drug administration
- Contraindications to contrast imaging
- Conditions that pose safety risks as judged by investigators
- Pregnancy
- Current participation in another experimental intervention trial
- Anticoagulation with INR above 1.7 if on warfarin (dabigatran reversal allowed)
- Other standard contraindications to thrombolysis aside from time window
- Terminal illness with life expectancy less than one year
- Planned withdrawal or comfort care measures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day
Participants receive a single intra-arterial injection of tenecteplase or placebo at the completion of thrombectomy for acute ischemic stroke.
1 treatment visit (in-person)
Duration - Up to 3 months
Participants are monitored for recovery and functional outcomes after treatment.
Approximately 3 to 4 visits including assessments at 24 hours, 36 hours, and 3 months
Trial Site Locations
Total: 12 locations
1
Gold Coast Univeristy Hospital
Gold Coast, Queensland, Australia
Actively Recruiting
2
Royal Adelaide Hospital
Adelaide, Australia
Actively Recruiting
3
Alfred Hospital
Melbourne, Australia
Actively Recruiting
4
Austin Hospital
Melbourne, Australia
Actively Recruiting
5
Monash Medical Centre
Melbourne, Australia
Actively Recruiting
6
Royal Melbourne Hospital
Melbourne, Australia
Actively Recruiting
7
Fiona Stanley Hospital
Perth, Australia
Actively Recruiting
8
Sir Charles Gairdner Hospital
Perth, Australia
Actively Recruiting
9
Liverpool Hospital
Sydney, Australia
Actively Recruiting
10
Royal North Shore Hospital
Sydney, Australia
Actively Recruiting
11
Townsville University Hospital
Townsville, Australia
Actively Recruiting
12
Christchurch Hospital
Christchurch, New Zealand
Not Yet Recruiting
Research Team
F
Felix Ng
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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