This study will address the efficacy and safety of Tenecteplase administered in non-endovascular capable center (nECC) in patients with acute ischemic stroke (AIS) caused by anterior circulation large vessel occlusion (acLVO) who present in the 4.5- to 24-hour time window before interhospital transfer to an endovascular capable center (ECC) for endovascular treatment (EVT). * Primary objective: To evaluate the efficacy and safety of Tenecteplase administration at a nECC before EVT transfer compared with standard of care * Secondary objective: To evaluate the impact of time from needle-to-arterial puncture on clinical outcomes Patients who meet inclusion criteria will be randomized to Tenecteplase (0.25mg/kg, maximum 25mg) before transfer or standard of care. A single bolus dose should be injected over 5 seconds.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
572
Tenecteplase at a nECC before EVT transfer
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGAffiliated Hospital of Shandong Second Medical University
Weifang, Shandong, China
RECRUITINGLevel of disability (ordinal mRS score)
the ordinal score on the modified Rankin scale; The modified Rankin scale is a measure of disability, with scores ranging from 0 (no symptoms) to 6 (death).
Time frame: at 90 (±7) days
Excellent outcome
mRS of 0-1 vs. 2-6
Time frame: at 90 (±7) days
Functional independence
mRS of 0-2 vs. 3-6
Time frame: at 90 (±7) days
Ambulatory and self-care capable
mRS of 0-3 vs. 4-6
Time frame: at 90 (±7) days
Health-related quality of life
Score on the EuroQol Group 5-Dimension 5-Level \[EQ-5D-5L\] questionnaire; range, -0.39 to 1, with higher scores indicating better quality of life)
Time frame: at 90 (±7) days
Incidence of arterial recanalization
Arterial imaging performed at ECC arrival, either CTA/MRA/or first run of DSA
Time frame: Day 1
First pass reperfusion
First pass reperfusion refers to achievement of recanalization by single pass, near-complete to complete recanalization of the occlusion site (eTICI 2c or 3) and no need for rescue treatment
Time frame: intraoperative, immediately after the first pass
Successful reperfusion
successful reperfusion is defined as extended Treatment In Cerebral Ischemia (eTICI) grades of 2b, 2c or 3
Time frame: immediately after the endovascular intervention
Recanalization
Time frame: at 24 (±12) hours
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