The goal of this clinical trial is to learn if immediate intra-arterial tirofiban after complete recanalization can improve recovery in adults with acute ischemic stroke caused by anterior circulation large-vessel occlusion. It will also learn about the safety of this treatment. The main questions it aims to answer are: Does immediate intra-arterial tirofiban after complete recanalization increase the number of participants with good functional outcome at 90 days? Does this treatment increase the risk of symptomatic intracranial hemorrhage or other important bleeding events? Researchers will compare immediate intra-arterial tirofiban with no intra-arterial tirofiban after complete recanalization to see if tirofiban improves recovery and is safe. Participants will: Be enrolled after mechanical thrombectomy achieves complete recanalization Be randomly assigned to receive intra-arterial tirofiban or no intra-arterial tirofiban Receive follow-up assessments during hospitalization and at 90 days
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
344
Immediate intra-arterial tirofiban (0.5 mg) infusion administered after achieving eTICI 2c-3 complete recanalization in patients with acute ischemic stroke due to large-vessel occlusion. The infusion is delivered over 10 minutes (1 mL/min).
Shandong Provincial Hospital, Affiliated to Shandong First Medical University
Jinan, Shandong, China
Proportion of Participants with Modified Rankin Scale (mRS) Score 0-1 at 90±7 Days
The primary outcome of this study is the proportion of participants with a modified Rankin Scale (mRS) score of 0-1 at 90±7 days, indicating functional independence after treatment with intra-arterial tirofiban following mechanical thrombectomy for acute ischemic stroke due to large-vessel occlusion
Time frame: 90±7 Days
Proportion of Participants with Modified Rankin Scale (mRS) 0-2 at 90±7 Days
The secondary outcome of this study is the proportion of participants with a modified Rankin Scale (mRS) score of 0-2 at 90±7 days, indicating mild disability after treatment with intra-arterial tirofiban following mechanical thrombectomy for acute ischemic stroke due to large-vessel occlusion.
Time frame: 90±7 days
Proportion of Participants with mRS 0-3 at 90±7 Days
This secondary outcome measures the proportion of participants with a modified Rankin Scale (mRS) score of 0-3 at 90±7 days, indicating moderate disability
Time frame: 90±7 Days
Symptomatic Intracranial Hemorrhage (sICH) within 48 Hours
This secondary outcome evaluates the incidence of symptomatic intracranial hemorrhage (sICH) within 48 hours after treatment.
Time frame: 48 hours
Any Intracranial Hemorrhage (ICH) within 48 Hours
This outcome measures the occurrence of any intracranial hemorrhage (ICH) within 48 hours following the intervention
Time frame: 48 hours
90-Day All-Cause Mortality
This secondary outcome evaluates the all-cause mortality rate at 90±7 days.
Time frame: 90±7 days
Early Neurological Improvement (≥10-point decrease in NIHSS) at 48 hours
This secondary outcome assesses the early neurological improvement, defined as a ≥10-point decrease in the NIHSS score at 48 hours.
Time frame: 48 hours
Quality of Life (EQ-5D-5L) at 90±7 Days
This outcome measures the quality of life using the EQ-5D-5L scale at 90±7 days.
Time frame: 90±7 days
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