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

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

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

Treatments tested in this trial

  • Intra-arterial tenecteplase injection at the completion of thrombectomy
  • Placebo

Treatment groups

462 Participants
are divided into 2 treatment groups

Sponsors and collaborators