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 a endovascular capable center (ECC) for endovascular treatment (EVT). * Primary objective: To evaluate the efficacy of Tenecteplase administration at a nECC before EVT transfer compared with direct transfer on 90-day function outcomes; * Secondary objective and further: To evaluate the safety of Tenecteplase administration at a nECC before EVT transfer; 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) administered before transfer or direct transfer to ECCs. 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
RECRUITINGOrdinal 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
Dichotomized mRS of 0-1 vs. 2-6
Time frame: at 90 (±7) days
Dichotomized mRS of 0-2 vs. 3-6
Time frame: at 90 (±7) days
Dichotomized mRS of 0-3 vs. 4-6
Time frame: at 90 (±7) days
Score on the EQ-5D-5L
Health-related quality of life (the 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
Recanalization
Time frame: at 24 (±12) hours
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
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