Extending the Time for Thrombolysis in Emergency Neurological Deficits - Intra-Arterial Using Intravenous Tenecteplase
Overview
- Phase
- Phase 2
- Intervention
- Tenecteplase
- Conditions
- Ischemic Stroke
- Sponsor
- Neuroscience Trials Australia
- Enrollment
- 202
- Locations
- 18
- Primary Endpoint
- 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.
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Arms & Interventions
Intravenous tenecteplase (TNK)
Patients will receive intravenous tenecteplase (0.25mg/kg, maximum 25mg, administered as a bolus over \~10 seconds).
Intervention: Tenecteplase
Intravenous tissue plasminogen activator (tPA)
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.
Intervention: Tissue Plasminogen Activator
Outcomes
Primary Outcomes
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.
Time Frame: Initial angiogram (day 0)
Secondary Outcomes
- 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)
- 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)
- Death due to any cause(Up to 3 months post stroke)
- 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)