In this pilot safety study, the investigators will give a second dose of Intravenous Tenecteplase (IV TNK) to patients receiving the initial TNK dose within 3 hrs of last known normal (LKN), have a baseline National Institutes of Health Stroke Scale (NIHSS) \> 6, and who do not clinically improve within 45 minutes of the first dose, or who improve but then deteriorate, and can still be treated within 4.5 hours from LKN. Patients will require a second computed tomography (CT) scan to rule out any bleeding, and meet the usual inclusion and exclusion criteria for TNK treatment, before the second dose which must be given within 4.5 hrs of LKN. Both TNK doses will be 0.25 mg/kg. The initial TNK dose may be given on the Mobile Stroke Unit (MSU) or Emergency Department (ED), and the second dose in the ED. Informed consent will be obtained before the second dose is given.
The primary outcome will be symptomatic intracranial hemorrhage (sICH) (SITS-MOST criteria) or serious systemic bleeding within 36 hours. Secondary outcomes will be any intracranial hemorrhage, any bleeding, discharge NIHSS and modified Rankin Score (mRS), and mRS at 90 days (sliding dichotomy).
20 patients will be enrolled. Enrollment will be stopped if more than 3 sICH occur (\> 80% confidence that sICH rate is \> 5%. If successful, this study will be followed by a larger phase 2b controlled safety confirmation and pilot efficacy study,
Signs and symptoms suggestive of acute ischemic stroke
Age > 18 and < 80 years
Time from LKN < 3 hrs (first dose) and <4.5 hours (second dose)
NIHSS > 6 and (for both first and second dose)
Patients with LVO or MeVO for whom EVT is intended at any time before the second dose of TENECTEPLASE
At the time of the second dose, NIHSS is < 6
Systolic blood pressure > 180 at the time of either dose of TENECTEPLASE
Pre-stroke mRS > 2
Single group
Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg)
DrugAll patients will receive a second dose of tenecteplase.
The number of patients with symptomatic intracerebral hemorrhage or major systemic bleeding
A type 2 parenchymal hemorrhage or a parenchymal hemorrhage remote from the area of infarction with neurological deterioration (≥4-point worsening in National Institutes of Health Stroke Scale) and major hemorrhage (requiring \>2 units packed red blood cells)
Clinical efficacy outcome
National Institutes of Health Stroke Scale (range 0-42 points with lower score indicating less severe stroke) and modified Rankin scale (range 0-6 with lower score indicating less disability)
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Memorial Hermann Health System
Lead sponsor
Grotta Stroke Research Foundation
Collaborator
Memorial Hermann Hospital Mobile Stroke Unit
Collaborator
The University of Texas Health Science Center, Houston
Collaborator
Genentech, Inc.
Collaborator
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