Tirofiban combined with Aspirin in the Treatment of Acute Penetrating Artery Territory Infarction (STRATEGY): protocol for a multicentre, randomised controlled trial.

IF 4.4 1区医学 Q1 CLINICAL NEUROLOGY

Stroke and Vascular Neurology Pub Date : 2024-02-27 DOI:10.1136/svn-2022-002284

Xiaoling Liao, Shuo Feng, Yicong Wang, Yuesong Pan, Weiqi Chen, Hui Qu, Xingquan Zhao, Liping Liu, Yongjun Wang, Yilong Wang

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引用次数: 0

Abstract

Background: Perforating artery territorial infarction (PAI) caused by branch atheromatous disease (BAD) is prone to recurrence and early progression without an effective and well-documented antiplatelet treatment regimen. Tirofiban, an adjunctive antiplatelet agent, has shown great potential to treat acute ischaemic stroke. However, whether the combination of tirofiban and aspirin can improve the prognosis of PAI remains unclear.

Aim: To explore an effective and safe antiplatelet regimen for reducing the risk of recurrence and early neurological deterioration (END) in PAI caused by BAD by comparing the tirofiban and aspirin combination with placebo and aspirin combination.

Methods: Tirofiban combined with Aspirin in the Treatment of Acute Penetrating Artery Territory Infarction (STRATEGY) trial is an ongoing multicentre, randomised, placebo-controlled trial in China. Eligible patients shall be randomly assigned to receive standard aspirin with tirofiban or placebo on the first day and standard aspirin from days 2 to 90. The primary endpoint is a new stroke or END within 90 days. The primary safety endpoint is severe or moderate bleeding within 90 days.

Discussion: The STRATEGY trial will assess whether tirofiban combined with aspirin is effective and safe in preventing recurrence and END in patients with PAI.

Trial registration number: NCT05310968.

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替罗非班联合阿司匹林治疗急性穿通性动脉梗塞（STRATEGY）：多中心随机对照试验方案。

背景：由动脉粥样硬化性分支疾病（BAD）引起的穿孔动脉区域性梗死（PAI），如果没有有效且证据充分的抗血小板治疗方案，很容易复发和早期进展。替罗非班作为一种辅助抗血小板药物，在治疗急性缺血性卒中方面已显示出巨大的潜力。目的：通过比较替罗非班和阿司匹林联合用药与安慰剂和阿司匹林联合用药，探索一种有效、安全的抗血小板治疗方案，以降低由 BAD 引起的 PAI 复发和早期神经功能恶化（END）的风险：方法："替罗非班联合阿司匹林治疗急性穿透性动脉梗死（STRATEGY）"试验是一项正在中国进行的多中心、随机、安慰剂对照试验。符合条件的患者将被随机分配到第一天接受标准阿司匹林联合替罗非班或安慰剂治疗，第2至90天接受标准阿司匹林治疗。主要终点为 90 天内新发中风或END。主要安全性终点是90天内严重或中度出血：STRATEGY试验将评估替罗非班联合阿司匹林在预防PAI患者复发和END方面是否有效和安全：试验注册号：NCT05310968。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Stroke and Vascular Neurology Medicine-Cardiology and Cardiovascular Medicine

CiteScore

11.20

自引率

1.70%

发文量

审稿时长

15 weeks

期刊介绍： Stroke and Vascular Neurology (SVN) is the official journal of the Chinese Stroke Association. Supported by a team of renowned Editors, and fully Open Access, the journal encourages debate on controversial techniques, issues on health policy and social medicine.