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.
This study is a multicenter, prospective, open-label, blinded endpoint, randomized controlled trial designed to evaluate 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 (eTICI 2b50/3). The primary outcome is the proportion of patients with a 90-day modified Rankin scale (mRS) of 0-1. Study intervention: (1) Participants in the experimental group will receive intra-arterial alteplase (a dose of 0.225 mg/kg and a maximum dose of 20 mg) after the mechanical thrombectomy, and will receive standard medical treatment after the procedure. (2) Participants in the control group will receive standard medical treatment without intra-arterial alteplase. A total of 324 participants are anticipated to be recruited for this study, with 162 participants in each group (1:1 ratio).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
324
See arm/group descriptions.
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
Shenzhen Hospital of Southern Medical University
Shenzhen, Guangdong, China
The modified Rankin Scale score (mRS) 0-1
The proportion of the modified Rankin Scale score (mRS) 0-1 at 90 days.
Time frame: 90(±7) 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
Time frame: 7(±1) days
The volume of Tmax>6s on CTP
The volume of Tmax\>6s on CTP at 24(±12) hours
Time frame: 24(±12) hours
The shift analysis of the modified Rankin Scale (mRS)
The shift analysis of the modified Rankin Scale (mRS) at 90 days
Time frame: 90(±7) days
The modified Rankin Scale score (mRS) 0-2
The proportion of the modified Rankin Scale score (mRS) 0-2 at 90 days.
Time frame: 90(±7) days
The modified Rankin Scale score (mRS) 0-3
The proportion of the modified Rankin Scale score (mRS) 0-3 at 90 days.
Time frame: 90(±7) days
The proportion of NIHSS 0-1 or ≥10 points reduction
The proportion of NIHSS 0-1 or ≥10 points reduction at 48 (±12) hours
Time frame: 48 (±12) hours
Quality of Life (EQ-5D-5L)
The value of Quality of Life (EQ-5D-5L) at 90 days
Time frame: 90(±7) days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.