Abstract Body: Background The Chemical Optimization of Cerebral Embolectomy (CHOICE) study suggested that the use of adjunct intra-arterial alteplase after successful endovascular reperfusion in large vessel occlusion acute ischemic strokes may result in a greater likelihood of excellent neurological outcome at 90 days. However, CHOICE was a phase-2 trial and almost exclusively enrolled anterior circulation occlusions. Therefore, data on the safety and efficacy of post-endovascular reperfusion intra-arterial thrombosis in posterior circulation stroke is lacking.
Objective To explore the efficacy and safety of intra-arterial alteplase after successful mechanical thrombectomy in patients with acute large vessel occlusion strokes involving the posterior circulation.
Design Multicenter, randomized, open-label, outcome assessor–blinded trial conducted in China. Participants presenting with acute ischemic stroke due to basilar artery occlusion or vertebral artery occlusion without antegrade flow to the basilar artery and receiving successful thrombectomy (an expanded Treatment in Cerebral Ischemia angiographic score ≥2b50) within 24 hours after stroke onset will be recruited and randomized.
Sample Size: Expected to require 376 subjects. One interim analysis will be performed when the enrollment volume reaches 50% of the total sample size (188 cases) to re-estimate the sample size and assess futility. DSMB will determine the premature termination or continuity of research.
Intervention Included patients will be randomized (1:1) to intra-arterial alteplase (0.225 mg/kg; maximum dose, 22.5 mg) infused over 15 minutes (n = 188) or none (n = 188).
Outcome Measure The primary outcome was the proportion of 90-day modified Rankin Scale (range, 0 [no symptoms] to 6 [death]) 0-2 in all patients treated as randomized. Safety outcomes included rate of symptomatic intracranial hemorrhage and death.
Analysis The intention to treat principle will be applied in all analyses.
Trial Status: The study has been registered on ClinicalTrials.gov (Identifier: NCT05897554) and enrollment is ongoing.
Sponsor: Xuanwu Hospital of Capital Medical University.