NCT05892510RecruitingPhase 2/3
Post-thrombectomy Intra-arterial Tenecteplase for Acute manaGement of Non-retrievable Thrombus and No-reflow in Emergent Stroke
Post-thrombectomy Intra-arterial Tenecteplase for Acute manaGement of Non-retrievable Thrombus and No-reflow in Emergent Stroke (EXTEND-AGNES TNK)
Source: ClinicalTrials.gov · Last updated 18 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 462 (estimated)
- First submitted
- 26 May 2023
- Start date
- 1 Jun 2024
- Primary completion date
- 30 Aug 2027
- Lead sponsor
- University of Melbourne
- Diseases
- Stroke
- NCT number
- NCT05892510
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 462
- From 1 Jun 2024 to the primary completion date, 30 Aug 2027
- 12 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Alteplase being infused within 30 minutes (\~5x half-life) of anticipated trial drug administration
Other illness
- Intracranial hemorrhage identified by CT or MRI
- Any condition (eg.mid-arterial phase early venous filling) that in the judgment of investigators could impose hazards if study therapy is initiated
- Known terminal illness such that the participants would not be expected to survive a year.
Lab values
- Anticoagulation. INR ≤1.7 if on warfarin, and dabigatran reversal by idarucizumab are permitted.
Other
- 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
- Contraindication to imaging with contrast agents
- Pregnant women.
- Current participation in another intervention research study that includes experimental interventions beyond standard-of-care.
- Other standard contraindications to thrombolysis apart from time window.
- Planned withdrawal of care or comfort care measures.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal Adelaide Hospital Coordinator of this site? Confirm its status | Adelaide | Australia | Recruiting |
| Gold Coast Univeristy Hospital Coordinator of this site? Confirm its status | Gold Coast | Australia | Recruiting |
| Austin Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| Alfred Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| Monash Medical Centre Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| Royal Melbourne Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| Fiona Stanley Hospital Coordinator of this site? Confirm its status | Perth | Australia | Recruiting |
| Sir Charles Gairdner Hospital Coordinator of this site? Confirm its status | Perth | Australia | Recruiting |
| Royal North Shore Hospital Coordinator of this site? Confirm its status | Sydney | Australia | Recruiting |
| Liverpool Hospital Coordinator of this site? Confirm its status | Sydney | Australia | Recruiting |
| Townsville University Hospital Coordinator of this site? Confirm its status | Townsville | Australia | Recruiting |
| Christchurch Hospital Coordinator of this site? Confirm its status | Christchurch | New Zealand | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.