Background: Intravenous thrombolysis remains a standard treatment for acute ischemic stroke within 4.5 hours after onset. Vascular reocclusion may occur after intravenous thrombolysis and may be preventable with an antiplatelet agent within the first 24 hours after thrombolysis. Tirofiban, a platelet glycoprotein IIb-IIIa receptor antagonist, has reduced macrovascular reocclusion in experimental models.
Methods: In this phase 3, multicenter, double-blind, randomized, placebo-controlled trial conducted at 38 centers in China, we assigned patients with acute ischemic noncardioembolic stroke who presented within 4.5 hours after stroke onset and who were not eligible for thrombectomy to receive a 24-hour intravenous infusion of tirofiban or placebo within 60 minutes after intravenous thrombolysis. The primary efficacy outcome was an excellent functional outcome, defined as a score of 0 to 1 on the modified Rankin scale, at 90 days. The safety outcomes were symptomatic intracranial hemorrhage within 36 hours and death at 90 days.
Results: A total of 414 patients were assigned to receive tirofiban and 418 to receive placebo. Thrombolytic agents included alteplase (in 75% of the patients) and tenecteplase (in 25%). At 90 days, a score of 0 to 1 on the modified Rankin scale was reported in a higher percentage of patients in the tirofiban group than in the placebo group (65.9% vs. 54.9%; risk ratio, 1.20; 95% confidence interval, 1.07 to 1.34; P = 0.001). Symptomatic intracranial hemorrhage occurred in 1.7% of the patients in the tirofiban group and none in the placebo group. Mortality at 90 days was 4.1% in the tirofiban group and 3.8% in the placebo group.
Conclusions: In patients with acute ischemic noncardioembolic stroke who underwent thrombolysis within 4.5 hours after onset, early tirofiban increased the likelihood of an excellent functional outcome. The incidence of intracranial hemorrhage was low but higher with tirofiban than placebo. (Funded by the Fundamental Research Funds for Central Universities; ASSET-IT ClinicalTrials.gov number, NCT06134622.).
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