Extending the Time Window for Tenecteplase by Effective Reperfusion in Patients With Large Vessel Occlusion (ETERNAL-LVO)

This is an interventional treatment trial for Ischemic Stroke Read More

Inclusion Criteria:

• Patients presenting with acute hemispheric ischemic stroke with onset (or the time they last known to be well) within 24 hours.
• Patient's age is ≥18 years.
• Premorbid mRS <3, with a concurrent assessment of whether the patient was able, immediately prior to the stroke, to: 1) Drive, or (if never drives) perform own Domestic duties, and 2) Shop for themselves, and 3) Bank/do their own finances (i.e. Drive/Domestic, Bank, Shop = DBS +ve). Need to be DBS +ve to be study eligible.
• Presence of a vessel occlusion on CTA or MRA. LVO will be defined as 'potentially retrievable' thrombus at one or more of the following sites: intracranial internal carotid (ICA), middle cerebral artery (MCA) first segment (M1), proximal middle cerebral artery second segment (M2) or isolated/tandem occlusion of the extracranial ICA. Patients with an extracranial ICA stenosis and occlusion are also eligible.
• Presence of 'target mismatch' on automated perfusion CT (CTP) or diffusion-perfusion MRI software defined as an ischemic core of <70mL, penumbra of >20mL and an ischemic core to perfusion lesion ratio of >1.8

Exclusion Criteria:

• Intracranial hemorrhage (ICH) or other diagnosis (e.g. tumor).
• Basilar Artery occlusion.
• Extensive early ischemic change (hypodensity on NCCT or high signal on DWI-MRI) or early ischemic change outside the perfusion lesion that invalidates mismatch criteria.
• Pre-stroke mRS score of > 2 (indicating significant previous disability) or DBS -ve.
• Any terminal illness such that patient would not be expected to survive more than 1 year
• Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.
• Pregnant women.
• Other standard contraindications to thrombolysis.
• Minor stroke symptoms, or major stroke symptoms rapidly improving
• Clinical presentation suggesting subarachnoid haemorrhage
• Known bleeding diasthesis and/or platelet count <100,000 or taking warfarin with INR > 1.7.
• Patients who have received heparin within 48 hours must have normal aPTT.
• Major surgery or serious trauma within 14 days, serious head trauma within 3 months.
• GI or urinary tract haemorrhage within last 21 days
• Arterial puncture at a non-compressible site or lumbar puncture within 7 days
• Systolic BP > 185, diastolic BP > 110mmHg
• Clinical stroke within 3 months or history of ICH
• Unable to gain consent from patient or person responsible
• Known severe renal impairment (GFR < 15mls/min)