Tenecteplase Versus Alteplase Before Endovascular Therapy for Ischemic Stroke

Neuroscience Trials Australia202 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

202

Conditions

Ischemic Stroke

Interventions

TenecteplaseDRUG

Tissue Plasminogen ActivatorDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients presenting with acute ischemic stroke eligible using standard criteria to receive IV thrombolysis within 4.5 hours of stroke onset 2. Patient's age is ≥18 years 3. Intra-arterial clot retrieval treatment can commence (arterial puncture) within 6 hours of stroke onset. 4. Arterial occlusion on CTA or MRA of the ICA, M1, M2 or basilar artery. Exclusion Criteria: 1. Intracranial hemorrhage (ICH) identified by CT or MRI 2. Rapidly improving symptoms at the discretion of the investigator 3. Pre-stroke mRS score of ≥ 4 (indicating previous disability) 4. Hypodensity in \>1/3 MCA territory or equivalent proportion of basilar artery territory on non-contrast CT 5. Contra indication to imaging with contrast agents 6. Any terminal illness such that patient would not be expected to survive more than 1 year 7. 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. 8. Pregnant women

Locations (18)

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Gosford Hospital

Gosford, New South Wales, Australia

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.

Time frame: Initial angiogram (day 0)

Modified Rankin Scale (mRS) at 3 months

ordinal analysis

Time frame: 3 months post stroke

mRS 0-1 or no change from baseline at 3 months

Time frame: 3 months post stroke

mRS 0-2 or no change from baseline at 3 months

Time frame: 3 months post stroke

Symptomatic intracranial hemorrhage (SICH)

Time frame: within 36 hours post treatment

Death due to any cause

Time frame: 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

Time frame: Up to 24 hours post treatment

Data from ClinicalTrials.gov

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