Chunrong Tao, Tianlong Liu, Jun Sun, Yuyou Zhu, Rui Li, Li Wang, Chao Zhang, Jianlong Song, Xiaozhong Jing, Thanh N Nguyen, Raul G Nogueira, Jeffrey L Saver, Wei Hu
{"title":"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。","authors":"Chunrong Tao, Tianlong Liu, Jun Sun, Yuyou Zhu, Rui Li, Li Wang, Chao Zhang, Jianlong Song, Xiaozhong Jing, Thanh N Nguyen, Raul G Nogueira, Jeffrey L Saver, Wei Hu","doi":"10.1177/17474930241299666","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Intravenous thrombolysis (IVT) is the cornerstone treatment for the acute ischemic stroke (AIS) within 4.5 h after onset. Current guidelines recommend administering antiplatelet medications 24 h after IVT. However, vascular reocclusion is a common occurrence after IVT. Tirofiban, a platelet glycoprotein IIb/IIIa antagonist, can help deter macrovascular reocclusion, prevent microvascular thrombosis, and enhance cerebral blood flow.</p><p><strong>Objective: </strong>This trial aims to assess whether early administration of tirofiban can improve clinical outcomes in patients with AIS who received IVT.</p><p><strong>Methods and design: </strong>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, multicenter 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.</p><p><strong>Outcomes: </strong>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 h and mortality at 90 days.</p><p><strong>Trial registry number: </strong>NCT06134622 (clinicaltrials.gov).</p>","PeriodicalId":14442,"journal":{"name":"International Journal of Stroke","volume":" ","pages":"17474930241299666"},"PeriodicalIF":6.3000,"publicationDate":"2024-11-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Advancing stroke safety and efficacy through early tirofiban administration after intravenous thrombolysis: The multicenter, randomized, placebo-controlled, double-blind ASSET IT trial protocol.\",\"authors\":\"Chunrong Tao, Tianlong Liu, Jun Sun, Yuyou Zhu, Rui Li, Li Wang, Chao Zhang, Jianlong Song, Xiaozhong Jing, Thanh N Nguyen, Raul G Nogueira, Jeffrey L Saver, Wei Hu\",\"doi\":\"10.1177/17474930241299666\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Intravenous thrombolysis (IVT) is the cornerstone treatment for the acute ischemic stroke (AIS) within 4.5 h after onset. Current guidelines recommend administering antiplatelet medications 24 h after IVT. However, vascular reocclusion is a common occurrence after IVT. Tirofiban, a platelet glycoprotein IIb/IIIa antagonist, can help deter macrovascular reocclusion, prevent microvascular thrombosis, and enhance cerebral blood flow.</p><p><strong>Objective: </strong>This trial aims to assess whether early administration of tirofiban can improve clinical outcomes in patients with AIS who received IVT.</p><p><strong>Methods and design: </strong>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, multicenter 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.</p><p><strong>Outcomes: </strong>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 h and mortality at 90 days.</p><p><strong>Trial registry number: </strong>NCT06134622 (clinicaltrials.gov).</p>\",\"PeriodicalId\":14442,\"journal\":{\"name\":\"International Journal of Stroke\",\"volume\":\" \",\"pages\":\"17474930241299666\"},\"PeriodicalIF\":6.3000,\"publicationDate\":\"2024-11-20\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"International Journal of Stroke\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1177/17474930241299666\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"CLINICAL NEUROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of Stroke","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/17474930241299666","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}
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 h after onset. Current guidelines recommend administering antiplatelet medications 24 h after IVT. However, vascular reocclusion is a common occurrence after IVT. Tirofiban, a platelet glycoprotein IIb/IIIa antagonist, can help deter macrovascular reocclusion, 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, multicenter 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 h and mortality at 90 days.
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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