To assess the efficacy and safety of tirofiban administration after intravenous thrombolysis for patients with AIS.
The standard treatment for acute ischemic stroke is intravenous thrombolysis to dissolve fibrin and restore blood flow. However, reocclusion of blood vessels and stroke progression remain challenges after this treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
832
Patients randomized to the Tirofiban group will receive continuous intravenous infusion of tirofiban for 24 hours: initial infusion of 0.4 μg/kg/min for 30 minutes followed by a continuous infusion of 0.1 μg/kg/min for up to 23.5 hours. The tirofiban placebo will be infused in a similar fashion.
placebo (saline)
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, China
a modified Rankin Score of 0-1
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
mortality
(Number of subjects who died at 90-day follow-up/total number of subjects who participated in 90-day follow-up) x100%
Time frame: 90 (± 14 days) after procedure
symptomatic intracerebral hemorrhage (ICH)
SICH means any hemorrhage with neurological deterioration, as indicated by an NIHSS score that was higher by ≥4 points than the value at baseline or the lowest value in the first 36 hours or any hemorrhage leading to death.
Time frame: within 36 hours after procedure
a modified Rankin Score of 0-3
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
Modified Rankin Score
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
NIHSS score
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.
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Time frame: 24 hours after procedure