Early tirofiban administration after intravenous thrombolysis in acute ischemic stroke (ADVENT): Study protocol of a multicenter, randomized, double-blind, placebo-controlled clinical trial.

Autor:	Guo ZN; Stroke Center, Department of Neurology, The First Hospital of Jilin University, Changchun, China.; Neuroscience Research Center, Department of Neurology, The First Hospital of Jilin University, Changchun, China., Zhang KJ; Stroke Center, Department of Neurology, The First Hospital of Jilin University, Changchun, China., Zhang P; Stroke Center, Department of Neurology, The First Hospital of Jilin University, Changchun, China., Qu Y; Stroke Center, Department of Neurology, The First Hospital of Jilin University, Changchun, China., Abuduxukuer R; Stroke Center, Department of Neurology, The First Hospital of Jilin University, Changchun, China., Nguyen TN; Department of Neurology, Radiology, Boston Medical Center, Boston University Chobanian and Avedisian School of Medicine, Boston, MA, USA., Chen HS; Department of Neurology, General Hospital of Northern Theater Command, Shenyang, China., Yang Y; Stroke Center, Department of Neurology, The First Hospital of Jilin University, Changchun, China.
Jazyk:	angličtina
Zdroj:	European stroke journal [Eur Stroke J] 2024 Jun; Vol. 9 (2), pp. 510-514. Date of Electronic Publication: 2024 Jan 09.
DOI:	10.1177/23969873231225069
Abstrakt:	Background: Nearly half of patients with acute ischemic stroke who undergo intravenous thrombolysis (IVT) fail to achieve excellent functional outcomes. Early administration of tirofiban after IVT may improve patient outcomes. Objective: To evaluate the efficacy and safety of early tirofiban administration after intravenous tenecteplase in patients with acute ischemic stroke. Methods and Design: The ADVENT trial is a multicenter, randomized, parallel-controlled, double-blind clinical trial. A total of 1084 patients undergoing IVT without subsequent endovascular treatment will be recruited from multiple hospitals in China. Subjects will be randomized in a 1:1 ratio to receive tirofiban or placebo, which will be infused within 6 h after IVT until 24 h after IVT, at 0.4 μg/kg/min for 30 min and then at 0.1 μg/kg/min. The primary efficacy outcome is the proportion of patients with excellent functional outcomes (modified Rankin Scale (mRS) ⩽ 1) at 90 days. Secondary outcomes include the proportion of patients with favorable functional outcomes (mRS ⩽ 2) at 90 days and neurological functional assessments evaluated during hospitalization. Symptomatic intracranial hemorrhage will be the primary safety outcome. Mortality and other adverse events will be recorded. Discussion: This pivotal trial will provide important data on the early administration of antiplatelet therapy after IVT and may promote progress in treatment standards. Trial Registry: ClinicalTrials.gov (NCT06045156). Competing Interests: Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Databáze:	MEDLINE
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