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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
462
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
Gold Coast Univeristy Hospital
Gold Coast, Queensland, Australia
RECRUITINGRoyal Adelaide Hospital
Adelaide, Australia
RECRUITINGPrincess Alexandra Hospital
Brisbane, Australia
NOT_YET_RECRUITINGRoyal Brisbane and Women's Hospital
Brisbane, Australia
NOT_YET_RECRUITINGCanberra Hospital
Canberra, Australia
NOT_YET_RECRUITINGAlfred Hospital
Melbourne, Australia
RECRUITINGAustin Hospital
Melbourne, Australia
RECRUITINGMonash Medical Centre
Melbourne, Australia
NOT_YET_RECRUITINGRoyal Melbourne Hospital
Melbourne, Australia
RECRUITINGJohn Hunter Hospital
Newcastle, Australia
NOT_YET_RECRUITING...and 3 more locations
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
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