Phase
Condition
Blood Clots
Cerebral Ischemia
Mental Disability
Treatment
Intra-arterial tenecteplase injection at the completion of thrombectomy
Placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adult participants (age≥18 years) presenting with ischemic stroke with arterial LVOon CT/MR Angiogram of the intracranial internal carotid or middle cerebral artery (MCA) first segment (M1) or proximal second segment (M2) committed to thrombectomyusing standard criteria within 24 hours of onset:
For 0-6 hours of symptom onset: Presence of arterial occlusion as defined above andASPECTS≥3 on NCCT
For 6-24 hours of symptom onset: Additional imaging criteria on CTP or MRI perfusionof core volume <100ml.
Qualifying CT/MR within 4hrs of randomisation (repeat CT for transferredparticipants required if >4hr)
Pre-stroke Modified Rankin Scale (mRS) score of ≤2 (mild pre-existing disabilitypermitted)
Local legal requirements for consent have been satisfied.
Exclusion
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 hoursfrom symptoms onset
Anticipated endovascular stenting required for intracranial or extracranialatherosclerotic stenosis/occlusion.
More than six retrieval attempts in the same vessel
Alteplase being infused within 30 minutes (~5x half-life) of anticipated trial drugadministration
Contraindication to imaging with contrast agents
Any condition (eg.mid-arterial phase early venous filling) that in the judgment ofinvestigators could impose hazards if study therapy is initiated
Pregnant women.
Current participation in another intervention research study that includesexperimental interventions beyond standard-of-care.
Anticoagulation. INR ≤1.7 if on warfarin, and dabigatran reversal by idarucizumabare permitted.
Other standard contraindications to thrombolysis apart from time window.
Known terminal illness such that the participants would not be expected to survive ayear.
Planned withdrawal of care or comfort care measures.
Study Design
Connect with a study center
Gold Coast Univeristy Hospital
Gold Coast, Queensland
AustraliaActive - Recruiting
Royal Adelaide Hospital
Adelaide,
AustraliaActive - Recruiting
Princess Alexandra Hospital
Brisbane,
AustraliaSite Not Available
Royal Brisbane and Women's Hospital
Brisbane,
AustraliaSite Not Available
Canberra Hospital
Canberra,
AustraliaSite Not Available
Alfred Hospital
Melbourne,
AustraliaActive - Recruiting
Austin Hospital
Melbourne,
AustraliaActive - Recruiting
Monash Medical Centre
Melbourne,
AustraliaSite Not Available
Royal Melbourne Hospital
Melbourne,
AustraliaActive - Recruiting
John Hunter Hospital
Newcastle,
AustraliaSite Not Available
Fiona Stanley Hospital
Perth,
AustraliaSite Not Available
Liverpool Hospital
Sydney,
AustraliaSite Not Available
Royal North Shore Hospital
Sydney,
AustraliaSite Not Available

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