A multicenter, prospective, open-label, blinded endpoint, randomized controlled trial aiming at evaluating the efficacy and safety of intra-arterial recombinant human tissue plasminogen activator (rt-PA) after successful recanalization of acute large vessel occlusion in the anterior circulation by mechanical thrombectomy in improving the 90-day functional outcome.
Aged 18 years or older.
Clinical diagnosis of acute ischemic stroke.
Time from symptom onset to randomization within 24 hours, including wake-up stroke or no-witness stroke; the onset time refers to "Last Known Well" (LKW).
CTA or MRA confirmed occlusion of the intracranial segment of the internal carotid artery, or M1 or M2 segment of the middle cerebral artery; stable eTICI score of 2b50-3 after mechanical thrombectomy, with or without intravenous thrombolysis. Patients with an eTICI score of 2b50-3 on the diagnostic cerebral angiography before mechanical thrombectomy are also eligible for the study.
Contraindication to rt-PA (except time to therapy).
Planned use of dual antiplatelet therapy within the first 24 hours after mechanical thrombectomy.
Angiographic evaluation showing dissection, severe stenosis, or complete occlusion of the carotid artery, which requires the use of carotid artery stents during the endovascular procedure.
Suspected cerebral vasculitis based on medical history and/or angiographic evaluation.
Parallel
Alteplase
DrugSee arm/group descriptions.
The modified Rankin Scale score (mRS) 0-1
The proportion of the modified Rankin Scale score (mRS) 0-1 at 90 days.
Change of infarct volume from baseline
The change of infarct volume at 7(±1) days or discharge (whichever occurred first) on non-contrast CT, or at 48(±12) hours on MRI
The volume of Tmax>6s on CTP
The volume of Tmax\>6s on CTP at 24(±12) hours
The shift analysis of the modified Rankin Scale (mRS)
The shift analysis of the modified Rankin Scale (mRS) at 90 days
The modified Rankin Scale score (mRS) 0-2
The proportion of the modified Rankin Scale score (mRS) 0-2 at 90 days.
SAFETY OUTCOME: Symptomatic intracranial hemorrhage
Symptomatic intracranial hemorrhage within 36 hours (according to Heidelberg criteria)
SAFETY OUTCOME: Mortality
Mortality at 90 days
SAFETY OUTCOME: Any intracranial hemorrhage
Any intracranial hemorrhage within 36 hours (according to Heidelberg criteria)
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Lead sponsor
Shenzhen Hospital of Southern Medical University
Collaborator
