A Phase 2/3 interventional study of Intra-arterial tenecteplase injection at the completion of thrombectomy and Placebo in Ischemic Stroke, Acute, Cerebrovascular Disorders and Brain Disorder, sponsored by University of Melbourne. Recruiting at 12 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-18.
Sponsored by University of Melbourne · Phase 2/3, Interventional, and Treatment
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.
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
This study's planned enrollment of 462 is above the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →University of Melbourne is the lead sponsor of 86 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intra-arterial bolus of placebo (0.9% Sodium Chloride solution) representing standard of care (no intra-arterial thrombolytic treatment).
Drug: Placebo
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: 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
intra-arterial bolus of 0.9% Sodium Chloride solution
Early Neurological Improvement (Phase 2b)
Proportion of participants with Early Neurological Improvement (ENI) defined as NIHSS reduction\>4
Time frame: 24-36 hours from time of randomisation
Functional independence (Phase 3)
Proportion of participants with Modified Rankin Scale (mRS) 0-2 (functional independence)
Time frame: 3 months
Functional improvement
Reduction of ≥ 1 mRS category (ordinal analysis merging mRS categories 5-6)
Time frame: 3 months
Infarct growth
Infarct growth volume on follow-up MRI or CT
Time frame: 24 hours
No-reflow
Proportion of participants with radiological no-reflow on MR perfusion or CTP
Time frame: 24 hours
Symptomatic Intracerebral Hemorrhage
Proportion of participants with sICH defined as parenchymal haematoma type 2 (PH2) or SAH/IVH within 36 hours combined with neurological deterioration leading to an increase of NIHSS ≥4 from baseline or leading to death
Time frame: 36 hours
All cause mortality
Proportion of participants with death due to any cause
Time frame: 3 months
Quality of life assessment on EQ-5D
EQ-5D score
Time frame: 3 months
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2024 (actual). Primary completion is estimated for Aug 2027, 38 months after the start.
Of 30 phase 2/3 interventional studies under Ischemic Stroke, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 55. This study's planned 38 months is above that.
How these figures are worked out, and which studies are left out of them.
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University of Melbourne