This study is designed to investigate the efficacy and safety of intravenous tenecteplase before interhospital transfer from a non-endovascular capable center(nECC) to an endovascular capable center (ECC) for thrombectomy in patients with acute ischemic stroke (AIS) caused by neuroimaging-confirmed acute basilar artery occlusion (BAO) between 4.5-24 hours of symptom onset.
This is a multicenter, prospective, open-label, blinded endpoint (PROBE), randomized controlled trial in patients with acute ischemic stroke due to BAO first presenting to a nECC and intending to undertake thrombectomy in an ECC. Patients will be required to have occlusion of the basilar artery on baseline computed tomography angiography (CTA)/magnetic resonance angiography (MRA) at the nECC. Patients will be randomized to either intravenous tenecteplase (0.25mg/kg, maximum 25mg)or not before interhospital transfer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
506
Patients will receive intravenous Tenecteplase 0.25 mg/kg body-weight up to a maximum of 25mg before the transfer. A single bolus dose should be administered over 5-10 seconds based on patient weight. Transfer to ECCs for thrombectomy should be initiated immediately after Tenecteplase administration.
Xuanwu Hospital, Capital Medical University
Beijing, China
RECRUITINGDichotomized mRS of 0-2 vs. 3-6
Dichotomized mRS of 0-2 vs. 3-6 at 90±7 days; modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death)
Time frame: 90±7 days
Ordinal mRS score
Ordinal mRS score at 90 (±7) days; modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death)
Time frame: 90 (±7) days
Dichotomized mRS of 0-1 vs. 2-6
Dichotomized mRS of 0-1 vs. 2-6 at 90 (±7) days
Time frame: 90 (±7) days
Dichotomized mRS of 0-3 vs. 4-6
Dichotomized mRS of 0-3 vs. 4-6 at 90 (±7) days
Time frame: 90 (±7) days
Early dramatic clinical response rate
Early dramatic clinical response rate at 24 (±12) h, defined as a NIHSS score of 0 or 2 or NIHSS drop of ≥8 from baseline
Time frame: 24 (±12) hours
Arterial recanalization during interhospital transfer
Arterial recanalization during interfacility transfer, evaluated with the angiography (CTA/MRA/first run of DSA) at ECC, and rated on the arterial occlusive lesion (AOL)
Time frame: At ECC before thrombectomy
Successful reperfusion
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Successful reperfusion at end-of-procedure angiography, defined as expanded Treatment in Cerebral Infarction (eTICI) score of 2b, 2c, or 3 on angiography
Time frame: At end-of-procedure angiography
First pass reperfusion
First pass reperfusion defined as eTICI 2c or greater after the first thrombectomy pass
Time frame: Immediately after the thrombectomy
Arterial recanalization
Arterial recanalization at 24(±12)h, evaluated with CTA/MRA and rated on the AOL
Time frame: 24(±12) hours
EQ-5D-5L
Score on the EQ-5D-5L at 90 (±7) days;(EQ-5D-5L: Minimum Score 5, Maximum score 25, lower scores mean a better quality of life).
Time frame: 90 (±7) days