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Trial record 1 of 1 for:    eternal-lvo | Recruiting, Not yet recruiting Studies | stroke
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Extending the Time Window for Tenecteplase by Effective Reperfusion in Patients With Large Vessel Occlusion (ETERNAL-LVO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04454788
Recruitment Status : Recruiting
First Posted : July 2, 2020
Last Update Posted : June 22, 2021
Sponsor:
Collaborator:
Professor Mark Parsons
Information provided by (Responsible Party):
Bruce Campbell, University of Melbourne

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Ischemic Stroke Drug: Tenecteplase Drug: Standard Care (which may include intravenous Alteplase) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 740 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Extending the Time Window for Tenecteplase by Effective Reperfusion of peNumbrAL Tissue in Patients With Large Vessel Occlusion
Actual Study Start Date : August 1, 2020
Estimated Primary Completion Date : June 1, 2025
Estimated Study Completion Date : December 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ischemic Stroke

Arms and Interventions
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Arm Intervention/treatment
Experimental: Intravenous tenecteplase (TNK)
Patients will receive intravenous tenecteplase (0.25mg/kg, maximum 25mg, administered as a bolus over 5-10 seconds).
 Drug: Tenecteplase
Genetically modified tissue plasminogen activator at a dose of 0.25mg/kg given as intravenous bolus over 5-10 seconds
Active Comparator: Intravenous tissue plasminogen activator (tPA)
Patients will receive standard of care (no intravenous thrombolytic treatment or intravenous alteplase 0.9mg/kg at the standard licensed dose of 0.9 mg/kg up to a maximum of 90mg, 10% as bolus and the remainder over 1 hour.
 Drug: Standard Care (which may include intravenous Alteplase)
Patients will receive standard care which may include intravenous alteplase at the standard licensed dose of 0.9 mg/kg up to a maximum of 90mg, 10% as bolus and the remainder over 1 hour.


Outcome Measures
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Primary Outcome Measures :
  1. Modified Rankin Scale (mRS) 0-1 (no disability) or return to baseline mRS [ Time Frame: 90 days ]
    Modified Rankin Scale (mRS) 0-1 (no disability) or return to baseline mRS (if baseline premorbid mRS =2) at 90 days


Secondary Outcome Measures :
  1. Early clinical improvement [ Time Frame: 24 hours ]
    Reduction in National Institutes of Health Stroke Scale (NIHSS) score of ≥8 points at 24 hours or reaching NIHSS 0-1

  2. Modified Rankin Scale (mRS) 0-2 (functional independence) [ Time Frame: 90 days ]
    Modified Rankin Scale (mRS) 0-2 (functional independence) at 90 days

  3. Substantial reperfusion at initial angiographic assessment [ Time Frame: initial angiography within 24 hours of stroke onset ]
    Proportion of patients with >50% reperfusion of the affected vascular territory (mTICI 3b/3) on initial digital subtraction angiography prior to thrombectomy

  4. Symptomatic intracerebral hemorrhage (sICH) [ Time Frame: 24 hours post-randomization ]
    sICH defined as parenchymal hematoma type 2 (PH2) - blood clot occupying >30% of the infarcted territory with substantial mass effect

  5. Death due to any cause [ Time Frame: 90 days ]
  6. Modified Rankin Scale (mRS) 5-6 [ Time Frame: 90 days ]
    Poor functional outcome of death or requirement for fulltime nursing care

  7. Successful reperfusion at 24 hours [ Time Frame: 24 hours ]
    Reperfusion (defined as >90% and >50% reduction in perfusion lesion volume)

  8. Infarct growth [ Time Frame: 24 hours ]
    Increase in the volume of irreversibly injured brain between pre-treatment and 24 hour imaging

  9. Recanalization [ Time Frame: 24 hours ]
    Change in vessel patency between pre-treatment and 24h imaging (CT or MR angiography)


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04454788


Contacts
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Contact: Andrew Bivard, PHD +6193424424 abivard@unimelb.edu.au
Contact: Amy McDonald, BN +6193424424 amym1@unimelb.edu.au

Locations
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Australia, New South Wales
Liverpool Hospital Recruiting
Liverpool, New South Wales, Australia
Contact: Dennis Cordato         
John Hunter Hospital Recruiting
Newcastle, New South Wales, Australia
Contact: Michelle Russell         
Prince of Wales Hospital Recruiting
Randwick, New South Wales, Australia
Contact: Ken Butcher       ken.butcher@unsw.edu.au   
Australia, Queensland
Princess Alexandra Hospital Recruiting
Woolloongabba 4102, Queensland, Australia, 4102
Contact: Helen Brown         
Australia, South Australia
Royal Adelaide Hospital Recruiting
Adelaide, South Australia, Australia, 5000
Contact: Tim Kleinig       tim.kleinig@sa.gov.au   
Australia, Victoria
Royal Melbourne Hospital Recruiting
Melbourne, Victoria, Australia, 3050
Contact: Amy McDonald         
Box Hill Hospital Recruiting
Melbourne, Victoria, Australia
Contact: Phillip Choi         
Sponsors and Collaborators
University of Melbourne
Professor Mark Parsons
More Information
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Responsible Party: Bruce Campbell, Prof, University of Melbourne
ClinicalTrials.gov Identifier: NCT04454788    
Other Study ID Numbers: 2019.125
First Posted: July 2, 2020    Key Record Dates
Last Update Posted: June 22, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ischemic Stroke
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
 Cardiovascular Diseases
Tissue Plasminogen Activator
Tenecteplase
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action