Post-thrombectomy Intra-arterial Tenecteplase for Acute manaGement of Non-retrievable Thrombus and No-reflow in Emergent Stroke
1 other identifier
interventional
462
1 country
13
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2024
Typical duration for phase_2
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 26, 2023
CompletedFirst Posted
Study publicly available on registry
June 7, 2023
CompletedStudy Start
First participant enrolled
June 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 30, 2027
July 25, 2025
March 1, 2025
3.2 years
May 26, 2023
July 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Early Neurological Improvement (Phase 2b)
Proportion of participants with Early Neurological Improvement (ENI) defined as NIHSS reduction\>4
24-36 hours from time of randomisation
Functional independence (Phase 3)
Proportion of participants with Modified Rankin Scale (mRS) 0-2 (functional independence)
3 months
Secondary Outcomes (6)
Functional improvement
3 months
Infarct growth
24 hours
No-reflow
24 hours
Symptomatic Intracerebral Hemorrhage
36 hours
All cause mortality
3 months
- +1 more secondary outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATORIntra-arterial bolus of placebo (0.9% Sodium Chloride solution) representing standard of care (no intra-arterial thrombolytic treatment).
Intra-arterial tenecteplase injection at the completion of thrombectomy
EXPERIMENTALintra-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
Interventions
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
Eligibility Criteria
You may qualify if:
- 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 within 24 hours of onset:
- 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)
- Local legal requirements for consent have been satisfied.
You may not qualify if:
- 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.
- More than six retrieval attempts in the same vessel
- Alteplase being infused within 30 minutes (\~5x half-life) of anticipated trial drug administration
- Contraindication to imaging with contrast agents
- Any condition (eg.mid-arterial phase early venous filling) that in the judgment of investigators could impose hazards if study therapy is initiated
- Pregnant women.
- Current participation in another intervention research study that includes experimental interventions beyond standard-of-care.
- Anticoagulation. INR ≤1.7 if on warfarin, and dabigatran reversal by idarucizumab are permitted.
- Other standard contraindications to thrombolysis apart from time window.
- Known terminal illness such that the participants would not be expected to survive a year.
- Planned withdrawal of care or comfort care measures.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Gold Coast Univeristy Hospital
Gold Coast, Queensland, Australia
Royal Adelaide Hospital
Adelaide, Australia
Princess Alexandra Hospital
Brisbane, Australia
Royal Brisbane and Women's Hospital
Brisbane, Australia
Canberra Hospital
Canberra, Australia
Alfred Hospital
Melbourne, Australia
Austin Hospital
Melbourne, Australia
Monash Medical Centre
Melbourne, Australia
Royal Melbourne Hospital
Melbourne, Australia
John Hunter Hospital
Newcastle, Australia
Fiona Stanley Hospital
Perth, Australia
Liverpool Hospital
Sydney, Australia
Royal North Shore Hospital
Sydney, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 26, 2023
First Posted
June 7, 2023
Study Start
June 1, 2024
Primary Completion (Estimated)
August 30, 2027
Study Completion (Estimated)
November 30, 2027
Last Updated
July 25, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share