Status:
TERMINATED
Extending the Time Window for Tenecteplase by Effective Reperfusion in Patients with Large Vessel Occlusion
Lead Sponsor:
University of Melbourne
Collaborating Sponsors:
Professor Mark Parsons
Conditions:
Ischemic Stroke
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 wit...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 6 2025
Estimated Enrollment :
242 Patients enrolled
Trial Details
Trial ID
NCT04454788
Start Date
August 1 2020
End Date
January 6 2025
Last Update
January 15 2025
Active Locations (7)
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1
Liverpool Hospital
Liverpool, New South Wales, Australia
2
John Hunter Hospital
Newcastle, New South Wales, Australia
3
Prince of Wales Hospital
Randwick, New South Wales, Australia
4
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102