A multicenter, double-blind, double-dummy, randomized trial evaluating the efficacy and safety of intravenous tirofiban in acute ischemic stroke (AIS) patients without large/medium vessel occlusion, who presented 4.5-24 hours after onset and received intravenous thrombolysis (IVT).
This study is a multicenter, double-blind, double-dummy, randomized clinical trial designed to evaluate the efficacy and safety of intravenous tirofiban in acute ischemic stroke (AIS) patients without large/medium vessel occlusion, who presented 4.5-24 hours after onset and received intravenous thrombolysis (IVT). 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 intervention group will receive intravenous tirofiban as soon as possible after the randomization. (2) Participants in the control group will receive matched intravenous placebo in the same approach. All participants will receive standard medical treatment. A total of 852 participants are anticipated to be recruited for this study, with 426 participants in each group (1:1 ratio).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
852
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
The modified Rankin Scale score (mRS) 0-1
The proportion of mRS score 0-1 at 90 (±14) days.
Time frame: 90 (±14) days
Distribution of modified Rankin Scale score at 90 days
The shift analysis of the 90-day mRS with 5-6 merged at 90 (±14) days.
Time frame: 90 (±14) days
The modified Rankin Scale score 0-2
The proportion of mRS score 0-2 at 90 (±14) days.
Time frame: 90 (±14) days
Early neurological improvement
The proportion of patients with a ≥30% decrease in National Institute of Health stroke scale score from baseline.
Time frame: 48 (±12) hours
Quality of life (EQ-5D-5L)
Health-related quality of life measured by EQ-5D-5L scale score at 90 (±14) days.
Time frame: 90 (±14) days
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