Intra-arterial Tenecteplase for Acute Ischemic Stroke

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

Recruiting Phase 2 Phase 3 Interventional Study
Ischemic Stroke, Acute Cerebrovascular Disorders Brain Disorder Central Nervous System Diseases
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
462 (estimated)
Sponsor
University of Melbourne · Other
Who this trial is looking for

This trial is looking for adults who have had an ischemic stroke caused by a blockage in specific brain arteries and are receiving a procedure called thrombectomy. Participants will receive a study treatment or standard care after the procedure.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am at least 18 years old.
  • I have been diagnosed with ischemic stroke.
  • I have a blockage in my brain's internal carotid or middle cerebral artery.
  • I can have thrombectomy within 24 hours of my stroke symptoms starting.
  • I had a pre-stroke disability score of 2 or less.
  • I had a qualifying brain scan within 4 hours before joining the trial.

You may not be able to join if

  • I have bleeding in my brain identified by a scan.
  • I have a low brain score (ASPECTS 0-2) on a brain scan.
  • I have a large area of brain tissue not getting blood if my stroke started 6-24 hours ago.
  • I need a stent for narrowing in my brain arteries.
  • I have had more than six attempts to retrieve the blockage in the same vessel.
  • I have recently received another blood clot treatment.
  • I am pregnant.
  • I am taking anticoagulants and have an INR above 1.7.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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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 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Adult participants (age≥18 years) presenting with ischemic stroke with arterial LVO on CT/MR Angiogram of the intracranial internal carotid or middle cerebral artery (MCA) first segment (M1) or proximal second segment (M2) committed to thrombectomy using standard criteria with…
Contacts

Felix Ng

+03 9342 7000

ng.f@unimelb.edu.au

CONTACT