Actively Recruiting
Post-thrombectomy Intra-arterial Tenecteplase for Acute manaGement of Non-retrievable Thrombus and No-reflow in Emergent Stroke
Led by University of Melbourne · Updated on 2025-07-25
462
Participants Needed
13
Research Sites
182 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Post-thrombectomy Intra-arterial Tenecteplase for Acute manaGement of Non-retrievable Thrombus and No-reflow in Emergent Stroke
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosis of ischemic stroke with arterial large vessel occlusion on CT or MR angiogram in the intracranial internal carotid artery or middle cerebral artery (M1 or proximal M2 segment)
- Eligible for mechanical thrombectomy within 24 hours of symptom onset
- For symptom onset 0-6 hours: ASPECTS score of 3 or higher on non-contrast CT
- For symptom onset 6-24 hours: Additional imaging criteria including core volume less than 100 ml on CT perfusion or MRI perfusion
- CT or MR imaging performed within 4 hours before randomization (repeat CT required if transferred and more than 4 hours have passed)
- Pre-stroke Modified Rankin Scale score of 2 or less indicating mild or no disability
- Local legal consent requirements fulfilled
You will not qualify if you...
- Presence of intracranial hemorrhage on CT or MRI
- ASPECTS score between 0 and 2 on non-contrast CT
- Ischemic core volume greater than 100 ml on CT perfusion or MRI perfusion if symptom onset is between 6 and 24 hours
- Planned endovascular stenting for intracranial or extracranial atherosclerotic stenosis or occlusion
- More than six retrieval attempts during thrombectomy in the same vessel
- Receiving alteplase infusion within 30 minutes prior to planned trial drug administration
- Contraindications to contrast imaging agents
- Any medical condition deemed by investigators to pose excessive risk if study therapy is started
- Pregnancy
- Current participation in another intervention research study involving experimental treatments beyond standard care
- Anticoagulation with INR over 1.7 if on warfarin (dabigatran reversal allowed)
- Standard contraindications to thrombolysis aside from time window
- Known terminal illness with life expectancy under one year
- Planned withdrawal of care or comfort care measures
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 13 locations
1
Gold Coast Univeristy Hospital
Gold Coast, Queensland, Australia
Actively Recruiting
2
Royal Adelaide Hospital
Adelaide, Australia
Actively Recruiting
3
Princess Alexandra Hospital
Brisbane, Australia
Not Yet Recruiting
4
Royal Brisbane and Women's Hospital
Brisbane, Australia
Not Yet Recruiting
5
Canberra Hospital
Canberra, Australia
Not Yet Recruiting
6
Alfred Hospital
Melbourne, Australia
Actively Recruiting
7
Austin Hospital
Melbourne, Australia
Actively Recruiting
8
Monash Medical Centre
Melbourne, Australia
Not Yet Recruiting
9
Royal Melbourne Hospital
Melbourne, Australia
Actively Recruiting
10
John Hunter Hospital
Newcastle, Australia
Not Yet Recruiting
11
Fiona Stanley Hospital
Perth, Australia
Not Yet Recruiting
12
Liverpool Hospital
Sydney, Australia
Not Yet Recruiting
13
Royal North Shore Hospital
Sydney, Australia
Not Yet Recruiting
Research Team
F
Felix Ng
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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