The purpose of this study is to determine the safety and feasibility of using intra-arterial Tenecteplase in patients undergoing blood clot extraction for treatment of acute ischemic (non-bleeding) stroke. Intravenous Tenecteplase is FDA-approved to treat patients with an ischemic stroke presenting within the 0-3-hour time window.
The primary objective of this study is to determine the safety and feasibility of intra-arterial Tenecteplase in selected patients with persistent post-thrombectomy hypoperfusion on computed tomography perfusion based on symptomatic intracranial hemorrhage (parenchymal hematoma type 2, subarachnoid hemorrhage, and/or intraventricular hemorrhage producing decline from the initial NIHSS of ≥ 4 points) at 24-36 hours.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
40
One-time dose of intra-arterial tenecteplase post-thrombectomy
One-time dose of intra-arterial saline post-thrombectomy
Atrium Health Neurosciences Institute
Charlotte, North Carolina, United States
Participants with Change in Symptomatic Intracranial Hemorrhage
Number of participants with symptomatic intracranial hemorrhage (parenchymal hematoma type 2, subarachnoid hemorrhage, and/or intraventricular hemorrhage) producing decline from the initial National Institutes of Health Stroke Scale (NIHSS) of ≥ 4 points.
Time frame: Hour 36
Participants with Parenchymal Hematoma Type 1
Number of participants with parenchymal hematoma type 1
Time frame: 24 Hours
Participants with Parenchymal Hematoma Type 2
Number of participants with parenchymal hematoma type 2
Time frame: 24 Hours
30-Day Mortality Count
Number of patients expired
Time frame: Day 30
90-Day Mortality Count
Number of patients expired
Time frame: Day 90
Number of Grade 3 Adverse Events
Total number of grade 3 adverse events
Time frame: Hour 24
Number of Grade 3 Adverse Events
Total number of grade 3 adverse events
Time frame: Day 5
Number of Grade 3 Adverse Events
Total number of grade 3 adverse events
Time frame: Day 30
Number of Grade 3 Adverse Events
Total number of grade 3 adverse events
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Time frame: Day 90