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Post-thrombectomy Intra-arterial Tenecteplase for Acute manaGement of Non-retrievable Thrombus and No-reflow in Emergent Stroke

ConditionsIschemic Stroke, AcuteCerebrovascular DisordersBrain DisorderCentral Nervous System Diseases
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Melbourne

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

For 0-6 hours of symptom onset: Presence of arterial occlusion as defined above and ASPECTS≥3 on NCCT

For 6-24 hours of symptom onset: Additional imaging criteria on CTP or MRI perfusion of core volume <100ml.

Qualifying CT/MR within 4hrs of randomisation (repeat CT for transferred participants required if >4hr)

Pre-stroke Modified Rankin Scale (mRS) score of ≤2 (mild pre-existing disability permitted)

Disqualifiers

Intracranial hemorrhage identified by CT or MRI

ASPECTS 0-2 on NCCT

CTP or MRI perfusion ischemic core volume >100ml if presenting within 6-24 hours from symptoms onset

Anticipated endovascular stenting required for intracranial or extracranial atherosclerotic stenosis/occlusion.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intra-arterial tenecteplase injection at the completion of thrombectomy

    Drug

    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

    Drug

    intra-arterial bolus of 0.9% Sodium Chloride solution

Treatment groups

462 Participants
are divided into 2 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: Intra-arterial tenecteplase injection at the completion of thrombectomyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

Functional independence (Phase 3)

Proportion of participants with Modified Rankin Scale (mRS) 0-2 (functional independence)

Time frame
3 months

Secondary outcomes

1

Functional improvement

Reduction of ≥ 1 mRS category (ordinal analysis merging mRS categories 5-6)

Time frame
3 months
2

Infarct growth

Infarct growth volume on follow-up MRI or CT

Time frame
24 hours
3

No-reflow

Proportion of participants with radiological no-reflow on MR perfusion or CTP

Time frame
24 hours
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Melbourne

Lead sponsor

Source ClinicalTrials.gov
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