Extending the Time Window for Tenecteplase by Effective Reperfusion in Patients With Large Vessel Occlusion

  • STATUS
    Recruiting
  • End date
    Dec 1, 2025
  • participants needed
    740
  • sponsor
    University of Melbourne
Updated on 1 July 2021
ct scan
stenosis
clot
stroke
thrombectomy
alteplase
plasminogen
probe
thrombolytic agent

Summary

Patients presenting to the emergency department with an acute ischemic stroke due to a large vessel occlusion eligible for thrombectomy and target mismatch on computed tomography perfusion imaging within 24 hours of onset will be assessed determine their eligibility for randomization into the trial. If the patient gives informed consent they will be randomised using a central computerised allocation process to either standard of care (no intravenous thrombolytic treatment or intravenous alteplase 0.9mg/kg) or tenecteplase before undergoing intra-arterial clot retrieval. The trial is prospective, randomised, open-label, blinded endpoint (PROBE) design.

Details
Condition Ischemic Stroke
Treatment Tenecteplase, Standard Care (which may include intravenous Alteplase)
Clinical Study IdentifierNCT04454788
SponsorUniversity of Melbourne
Last Modified on1 July 2021

Eligibility

Yes No Not Sure

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)
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