BridgeMD
New treatment option for Ischemic Stroke, Acute
Official title Post-thrombectomy Intra-arterial Tenecteplase for Acute manaGement of Non-retrievable Thrombus and No-reflow in Emergent Stroke
ClinicalTrials.gov ID: NCT05892510
What this study is testing
What is Intra-arterial tenecteplase injection at the completion of thrombectomy?
Intra-arterial tenecteplase injection at the completion of thrombectomy is an investigational medicine, being studied as a potential treatment for ischemic stroke, acute.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adult participants (age≥18 years) presenting with ischemic stroke with arterial LVO on CT/MR Angiogram of the intracranial internal carotid or middle...
- 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)
You likely can't join 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
See the full eligibility 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Gold Coast, Queensland, Australia
- Adelaide, Australia
- Melbourne, Australia
- Perth, Australia
- Sydney, Australia
- Townsville, Australia
- Christchurch, New Zealand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gold Coast, Queensland, Australia; Adelaide, Australia; Melbourne, Australia; Perth, Australia; Sydney, Australia; Townsville, Australia and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.