NCT05892510 Post-thrombectomy Intra-arterial Tenecteplase for Acute manaGement of Non-retrievable Thrombus and No-reflow in Emergent Stroke
| NCT ID | NCT05892510 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | University of Melbourne |
| Condition | Ischemic Stroke, Acute |
| Study Type | INTERVENTIONAL |
| Enrollment | 462 participants |
| Start Date | 2024-06-01 |
| Primary Completion | 2027-08-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 462 participants in total. It began in 2024-06-01 with a primary completion date of 2027-08-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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 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. Exclusion Criteria: * 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 & Investigator
Frequently Asked Questions
Who can join the NCT05892510 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Ischemic Stroke, Acute. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05892510 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05892510 currently recruiting?
Yes, NCT05892510 is actively recruiting participants. Contact the research team at ng.f@unimelb.edu.au for enrollment information.
Where is the NCT05892510 trial being conducted?
This trial is being conducted at Gold Coast, Australia, Adelaide, Australia, Melbourne, Australia, Melbourne, Australia and 8 additional locations.
Who is sponsoring the NCT05892510 clinical trial?
NCT05892510 is sponsored by University of Melbourne. The trial plans to enroll 462 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.