Tenecteplase Versus Alteplase Before Endovascular Therapy for Ischemic Stroke
- Conditions
- Ischemic Stroke
- Interventions
- Registration Number
- NCT02388061
- Lead Sponsor
- Neuroscience Trials Australia
- Brief Summary
Patients presenting to the emergency department with acute ischemic stroke, who are are eligible for standard intravenous tPA therapy within 4.5 hours of stroke onset will be assessed for major vessel occlusion to determine their eligibility for randomization into the trial. If the patient gives informed consent they will be randomised 50:50 using central computerised allocation to intravenous alteplase or tenecteplase before all participants undergo intra-arterial clot retrieval. The trial is prospective, randomised, open-label, blinded endpoint (PROBE) design.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 202
- Patients presenting with acute ischemic stroke eligible using standard criteria to receive IV thrombolysis within 4.5 hours of stroke onset
- Patient's age is ≥18 years
- Intra-arterial clot retrieval treatment can commence (arterial puncture) within 6 hours of stroke onset.
- Arterial occlusion on CTA or MRA of the ICA, M1, M2 or basilar artery.
- Intracranial hemorrhage (ICH) identified by CT or MRI
- Rapidly improving symptoms at the discretion of the investigator
- Pre-stroke mRS score of ≥ 4 (indicating previous disability)
- Hypodensity in >1/3 MCA territory or equivalent proportion of basilar artery territory on non-contrast CT
- Contra indication to imaging with contrast agents
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intravenous tenecteplase (TNK) Tenecteplase Patients will receive intravenous tenecteplase (0.25mg/kg, maximum 25mg, administered as a bolus over \~10 seconds). Intravenous tissue plasminogen activator (tPA) Tissue Plasminogen Activator Patients will receive intravenous t-PA 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.
- Primary Outcome Measures
Name Time Method Proportion of patients with substantial angiographic reperfusion (mTICI) score of 2b/3 (restoration of blood flow to >50% of the affected arterial territory) or absence of retrievable thrombus at initial angiogram. Initial angiogram (day 0)
- Secondary Outcome Measures
Name Time Method Death due to any cause Up to 3 months post stroke Proportion of patients with ≥8 point reduction in NIHSS or reaching 0-1 at 3 days (favourable clinical response) adjusted for baseline NIHSS and age. Initial angiogram (day 0) Modified Rankin Scale (mRS) at 3 months 3 months post stroke ordinal analysis
mRS 0-1 or no change from baseline at 3 months 3 months post stroke mRS 0-2 or no change from baseline at 3 months 3 months post stroke Symptomatic intracranial hemorrhage (SICH) within 36 hours post treatment Proportion of patients with angiographic reperfusion adjusted for hyperdense clot length on non-contrast CT and time from thrombolysis to initial angiogram Up to 24 hours post treatment
Trial Locations
- Locations (18)
Royal Prince Alfred Hospital
🇦🇺Camperdown, New South Wales, Australia
Gosford Hospital
🇦🇺Gosford, New South Wales, Australia
John Hunter Hospital
🇦🇺Newcastle, New South Wales, Australia
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
Box Hill Hospital
🇦🇺Box Hill, Victoria, Australia
Christchurch Hospital
🇳🇿Christchurch, New Zealand
Royal Melbourne Hospital
🇦🇺Melbourne, Victoria, Australia
Auckland Hospital
🇳🇿Grafton, Auckland, New Zealand
Lyell McEwin Hospital
🇦🇺Elizabeth Vale, South Australia, Australia
Princess Alexandra Hospital
🇦🇺Woolloongabba, Queensland, Australia
Gold Coast University Hospital
🇦🇺Gold Coast, Queensland, Australia
Royal Brisbane & Women's Hospital
🇦🇺Brisbane, Queensland, Australia
Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
Royal North Shore Hospital
🇦🇺St. Leonards, New South Wales, Australia
Western Heath
🇦🇺St Albans, Victoria, Australia
Austin Hospital
🇦🇺Heidelberg, Victoria, Australia
Monash Medical Centre
🇦🇺Clayton, Victoria, Australia