Ischemic Stroke, AcutePhase 2/3NCT05892510
Post-thrombectomy Intra-arterial Tenecteplase for Acute manaGement of Non-retrievable Thrombus and No-reflow in Emergent Stroke
A Phase 2/3 study testing Intra-arterial tenecteplase injection at the completion of thrombectomy in people with Ischemic Stroke, Acute and Cerebrovascular Disorders, run by University of Melbourne at 12 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Acute, Cerebrovascular Disorders, Brain Disorder
- What is being tested?
- Intra-arterial tenecteplase injection at the completion of thrombectomy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 462 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 1 Jun 2024to 30 Nov 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
12 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
12 sites in 2 countries
Australia11 sites, 11 recruiting
- Recruiting
Royal Adelaide Hospital
Adelaide
Roy Drew
Timothy Kleinig
- Recruiting
Gold Coast Univeristy Hospital
Gold Coast, Queensland
Peter Bailey
- Recruiting
Alfred Hospital
Melbourne
Pamela Galindo
Geoff Cloud
- Recruiting
Austin Hospital
Melbourne
Vincent Thijs
Vincent Thijs
- Recruiting
Monash Medical Centre
Melbourne
Henry Ma
Henry Ma
- Recruiting
Royal Melbourne Hospital
Melbourne
David Jackson
Felix Ng
- Recruiting
Fiona Stanley Hospital
Perth
Darshan Ghia
Darshan Ghia
- Recruiting
Sir Charles Gairdner Hospital
Perth
Timothy Phillips
- Recruiting
Liverpool Hospital
Sydney
Dennis Cordato
Dennis Cordato
- Recruiting
Royal North Shore Hospital
Sydney
Alice Ma
Alice Ma
- Recruiting
Townsville University Hospital
Townsville
Ravindra Urkude
New Zealand1 site, 1 recruiting
- Not yet recruiting
Christchurch Hospital
Christchurch
Teddy Wu
About this study
Official title: Post-thrombectomy Intra-arterial Tenecteplase for Acute manaGement of Non-retrievable Thrombus and No-reflow in Emergent Stroke (EXTEND-AGNES TNK)
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
- Ischemic Stroke, Acute, Cerebrovascular Disorders, Brain Disorder, Central Nervous System Diseases
- Being tested
- Intra-arterial tenecteplase injection at the completion of thrombectomy, Placebo
- Keywords
- Tenecteplase, Fibrinolytic agents, Thrombectomy, No-reflow
- Medical subject headings
- Ischemic Stroke, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-arterial tenecteplase injection at the completion of thrombectomyDrug
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
PlaceboDrug
intra-arterial bolus of 0.9% Sodium Chloride solution
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Intra-arterial bolus of placebo (0.9% Sodium Chloride solution) representing standard of care (no intra-arterial thrombolytic treatment). Receives: Drug: Placebo |
| Intra-arterial tenecteplase injection at the completion of thrombectomy | Experimental | 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 Receives: Drug: Intra-arterial tenecteplase injection at the completion of thrombectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Neurological Improvement (Phase 2b)
Proportion of participants with Early Neurological Improvement (ENI) defined as NIHSS reduction>4
Measured: 24-36 hours from time of randomisation
Functional independence (Phase 3)
Proportion of participants with Modified Rankin Scale (mRS) 0-2 (functional independence)
Measured: 3 months
Secondary outcomes (6)
Functional improvement
Reduction of ≥ 1 mRS category (ordinal analysis merging mRS categories 5-6)
Measured: 3 months
Infarct growth
Infarct growth volume on follow-up MRI or CT
Measured: 24 hours
No-reflow
Proportion of participants with radiological no-reflow on MR perfusion or CTP
Measured: 24 hours
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
Measured: 36 hours
All cause mortality
Proportion of participants with death due to any cause
Measured: 3 months
Quality of life assessment on EQ-5D
EQ-5D score
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start1 Jun 2024
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Stroke, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 462 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Melbourne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05892510
- Sponsor's protocol ID
- CT26024
- Status last verified
- Apr 2026
- First submitted
- 26 May 2023
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-thrombectomy Intra-arterial Tenecteplase for Acute manaGement of Non-retrievable Thrombus and No-reflow in Emergent Stroke (EXTEND-AGNES TNK)
- ClinicalTrials.gov ID
- NCT05892510
- Acronym / sponsor ID
- CT26024
- Conditions
- Ischemic Stroke, Acute, Cerebrovascular Disorders, Brain Disorder, Central Nervous System Diseases
- Keywords
- Tenecteplase, Fibrinolytic agents, Thrombectomy, No-reflow
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 462 participants (estimated)
- Lead sponsor
- University of MelbourneUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 7 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboIntra-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 | Experimental | Drug: Intra-arterial tenecteplase injection at the completion of thrombectomyintra-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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intra-arterial tenecteplase injection at the completion of thrombectomyIntra-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 | Drug | Intra-arterial tenecteplase injection at the completion of thrombectomy |
| Placebointra-arterial bolus of 0.9% Sodium Chloride solution | Drug | Placebo |
Primary outcome
Early Neurological Improvement (Phase 2b)
Time frame: 24-36 hours from time of randomisation
Proportion of participants with Early Neurological Improvement (ENI) defined as NIHSS reduction>4
Functional independence (Phase 3)
Time frame: 3 months
Proportion of participants with Modified Rankin Scale (mRS) 0-2 (functional independence)
6 secondary outcomes
Functional improvement
Time frame: 3 months
Infarct growth
Time frame: 24 hours
No-reflow
Time frame: 24 hours
Symptomatic Intracerebral Hemorrhage
Time frame: 36 hours
All cause mortality
Time frame: 3 months
Quality of life assessment on EQ-5D
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Intra-arterial tenecteplase injection at the completion of thrombectomy in people with Ischemic Stroke, Acute and Cerebrovascular Disorders, run by University of Melbourne at 12 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Felix Ng (+03 9342 7000, ng.f@unimelb.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early Neurological Improvement (Phase 2b) (time frame: 24-36 hours from time of randomisation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.