To assess the effect of intravenous tenecteplase plus endovascular thrombectomy (EVT) compared to EVT alone on 4.5 to 24 hours after stroke due to basilar artery occlusion.
Background and Rationale: Recently, two prospective multicenter RCT (ATTENTION and BAOCHE trials) have shown a significantly beneficial effect of EVT in patients with an acute symptomatic basilar artery occlusion. The EXTEND-IA TNK trial demonstrated that intravenous thrombolysis with tenecteplase is superior to alteplase before EVT for anterior circulation large vessel occlusion strokes. However, it is unclear whether intravenous tenecteplase bridging with EVT is superior to EVT alone in the extended window patients with basilar artery occlusion. Therefore, additional studies are needed to explore the potential benefit of intravenous tenecteplase in these patients. Study design: Multicenter, prospective, controlled clinical trial with open-label treatment and blind outcome assessment (PROBE) of intravenous tenecteplase plus EVT versus EVT alone. The trial has observer blinded assessment of the primary outcome and neuroimaging at baseline and follow up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
330
Patients will receive intravenous tenecteplase (0.25mg/kg, maximum 25mg, administered as a bolus over 5-10 seconds) before endovascular thrombectomy
The choice of endovascular thrombectomy strategy will be made by the treating neurointerventionist. All thrombectomy devices for endovascular treatment, which are approved by CFDA for this purpose, are allowed in the trial.
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, China
Proportion of patients with modified Rankin Score 0-2 at day 90 (±14 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 (± 14 days) after procedure
Proportion of patients with modified Rankin Score 0-3 at day 90 (±14 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 (± 14 days) after procedure
Ordinal Shift analysis of modified Rankin Score at day 90 (±14 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 (± 14 days) after procedure
Score on the NIHSS at 24 hours
The NIHSS is an ordinal hierarchical scale to evaluate the severity of stroke by assessing a patient's performance. Scores range from 0 to 42, with higher scores indicating a more severe deficit.
Time frame: 24 hours after procedure
Score on the NIHSS at 5-7 days or discharge
The NIHSS is an ordinal hierarchical scale to evaluate the severity of stroke by assessing a patient's performance. Scores range from 0 to 42, with higher scores indicating a more severe deficit.
Time frame: 5-7 days or discharge after procedure
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Proportion of patients with modified Rankin Score 0-1 at day 90 (±14 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 (± 14 days) after procedure
Proportion of patients with modified Rankin Score 0-4 at day 90 (±14 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 (± 14 days) after procedure
Score on the EuroQoL 5-dimensions 5-level (EQ5D-5L) at 90 days (±14 days)
Health-related quality of life, assessed with EQ-5D-5L
Time frame: 90 (± 14 days) after procedure
level of activities of daily living (Barthel index, BI) at 90 days (±14 days)
Level of activities of daily living
Time frame: 90 (± 14 days) after procedure
Successful reperfusion (Extended thrombolysis in cerebral infarction [eTICI] score 2b50-3) on digital substraction angiography (DSA) prior to thrombectomy
Evaluate effect of intravenous thrombolysis on reperfusion
Time frame: within 5 minutes at angiography
Successful reperfusion on final angiography of thrombectomy
Evaluate effect of thrombectomy on reperfusion
Time frame: Within 5 minutes at final angiography of thrombectomy
Successful recanalization on CT or MR angiography within 72 hours
Evaluate vascular patency after treatment
Time frame: Within 72 hours after procedure
Infarct volume (Posterior Circulation Acute Stroke Prognosis Early Computed Tomography Score, PC-ASPECTS) evaluated on CT or MRI within 72 hours
PC-ASPECTS=10 indicates a normal scan, PC-ASPECTS=0 indicates early ischemic changes or hypoattenuation in all above territories. 1 or 2 points each are subtracted for early ischemic changes or hypoattenuation in: left or right thalamus, cerebellum or posterior cerebral artery territory, respectively (1 point); any part of midbrain or pons (2 points)
Time frame: Within 72 hours after procedure