Zhang Fan, Xiao Minghui, Zhang Cong, Yuan Guangxiong, Xie Zhiyong, Yin Yi, Zhou Ruize, Yuan Shanggui, Xiao Genxiang, Mei Donghuan, Zeng Xiaobing, Liu Huashi, Li Huadong, Liu Hongwen, Tan Jinchang, Chen Bin, Fu Qingqing, Li Bin, Lai Jinxing, Sun Wei, Xie Shuhua, Lai Zhaohui, Qiu Zhongming, Jiang Zidian, Liu Xianghong, Zeng Guoyong
Ganzhou People's Hospital Ganzhou China.
People's Hospital of Wan'an City Wan'an China.
J Am Heart Assoc. 2025 Jul;14(13):e038536. doi: 10.1161/JAHA.124.038536. Epub 2025 Jun 27.
It is common that symptoms do not improve or even worsen after intravenous thrombolysis (IVT) in acute ischemic stroke. However, it remains unknown whether early administration of tirofiban after IVT may improve clinical outcomes. This trial aims to assess the efficacy and safety of early administration of tirofiban after IVT with tenecteplase in acute ischemic stroke during the 90-day follow-up period after treatment.
The INSTANT (Intravenous Tenecteplase and Tirofiban for Acute Ischemic Stroke) trial is an investigator-initiated, randomized, placebo-controlled, double-blind, multicenter trial. In the study, 310 patients with acute nonlarge/medium-sized vascular occlusion and nonatrial fibrillation stroke who are treated with intravenous tenecteplase will be consecutively randomized to intravenous tirofiban or placebo in a 1:1 ratio over 2 years across 50 intravenous thrombolysis-capable stroke centers in China. In addition, eligible subjects will receive best medical treatment according to national guidelines. The primary efficacy end point is excellent functional status, defined as a score of 0 or 1 on the modified Rankin Scale at 90 days after randomization. Safety outcomes include symptomatic intracranial hemorrhage within 48 hours and mortality at 90 days.
The INSTANT trial was designed to determine the role of tirofiban within 24 hours after IVT in patients with acute ischemic stroke. Our primary objective is to investigate whether the early administration of tirofiban following IVT can enhance the proportion of patients exhibiting no or minimal symptoms post acute ischemic stroke.
URL: ChiCTR2300074368; Unique Identifier: www.chictr.org.cn.
急性缺血性卒中患者静脉溶栓（IVT）后症状未改善甚至恶化的情况很常见。然而，IVT后早期使用替罗非班是否能改善临床结局仍不清楚。本试验旨在评估在急性缺血性卒中患者接受替奈普酶IVT治疗后的90天随访期内，早期给予替罗非班的疗效和安全性。
INSTANT（急性缺血性卒中静脉用替奈普酶和替罗非班）试验是一项由研究者发起的、随机、安慰剂对照、双盲、多中心试验。在该研究中，310例急性非大/中型血管闭塞且非房颤性卒中患者接受静脉替奈普酶治疗，将在2年时间内通过中国50个具备静脉溶栓能力的卒中中心，以1:1的比例连续随机分为静脉注射替罗非班组或安慰剂组。此外，符合条件的受试者将根据国家指南接受最佳药物治疗。主要疗效终点是良好的功能状态，定义为随机分组后90天改良Rankin量表评分为0或1分。安全结局包括48小时内有症状性颅内出血和90天死亡率。
INSTANT试验旨在确定替罗非班在急性缺血性卒中患者IVT后24小时内的作用。我们的主要目标是研究IVT后早期给予替罗非班是否能提高急性缺血性卒中后无症状或症状轻微患者的比例。
网址：ChiCTR23000
