通过静脉溶栓后早期应用替罗非班提高卒中安全性和疗效:多中心、随机、安慰剂对照、双盲 ASSET IT 试验方案。

IF 6.3 2区 医学 Q1 CLINICAL NEUROLOGY
Chunrong Tao, Tianlong Liu, Jun Sun, Yuyou Zhu, Rui Li, Li Wang, Chao Zhang, Jianlong Song, Xiaozhong Jing, Thanh N Nguyen, Raul Nogueira, Jeffrey L Saver, Wei Hu
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引用次数: 0

摘要

背景:静脉溶栓(IVT)是急性缺血性卒中(AIS)发病后 4.5 小时内的基础治疗方法。现行指南建议在静脉溶栓 24 小时后服用抗血小板药物。然而,IVT 后血管再闭塞的情况很常见。替罗非班是一种血小板糖蛋白IIb/IIIa拮抗剂,有助于阻止大血管再闭塞,防止微血管血栓形成,增强脑血流量:本试验旨在评估早期服用替罗非班是否能改善接受 IVT 的 AIS 患者的临床预后:通过静脉溶栓后早期服用替罗非班提高卒中安全性和疗效(ASSET IT)试验是一项由研究者发起的随机、安慰剂对照、双盲、多中心研究。中国 38 个卒中中心将按照 1:1 的比例连续随机安排多达 832 名符合条件的患者在 2 年内接受静脉注射替罗非班或安慰剂治疗:主要终点是第90天时功能状态良好,即改良Rankin评分为0-1分。主要安全性终点包括24小时内无症状性脑出血和90天时的死亡率。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Advancing Stroke Safety and Efficacy through Early Tirofiban Administration after Intravenous Thrombolysis: The multicenter, randomized, placebo-controlled, double-blind ASSET IT trial protocol.

Background: Intravenous thrombolysis (IVT) is the cornerstone treatment for the acute ischemic stroke (AIS) within 4.5 hours after onset. Current guidelines recommend administering antiplatelet medications 24 hours after IVT. However, vascular re-occlusion is a common occurrence after IVT. Tirofiban, a platelet glycoprotein IIb/IIIa antagonist, can help deter macrovascular re-occlusion, prevent microvascular thrombosis, and enhance cerebral blood flow.

Objective: This trial aims to assess whether early administration of tirofiban can improve clinical outcomes in patients with AIS who received IVT.

Methods and design: The Advancing Stroke Safety and Efficacy through Early Tirofiban Administration after Intravenous Thrombolysis (ASSET IT) Trial is an investigator-initiated, randomized, placebo-controlled, double-blind, multi-center study. Up to 832 eligible patients will be consecutively randomized in a 1:1 ratio to receive either intravenous tirofiban or placebo over a period of 2 years across 38 stroke centers in China.

Outcomes: The primary endpoint is excellent functional status at day 90, defined as a modified Rankin Score of 0-1. Primary safety endpoints include symptomatic intracerebral hemorrhage at 24 hours and mortality at 90 days.

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来源期刊
International Journal of Stroke
International Journal of Stroke 医学-外周血管病
CiteScore
13.90
自引率
6.00%
发文量
132
审稿时长
6-12 weeks
期刊介绍: The International Journal of Stroke is a welcome addition to the international stroke journal landscape in that it concentrates on the clinical aspects of stroke with basic science contributions in areas of clinical interest. Reviews of current topics are broadly based to encompass not only recent advances of global interest but also those which may be more important in certain regions and the journal regularly features items of news interest from all parts of the world. To facilitate the international nature of the journal, our Associate Editors from Europe, Asia, North America and South America coordinate segments of the journal.
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