Stroke and high-risk TIA outcomes with reduction of treatment duration when treatment initiated in emergency rooms (SHORTER-study).

IF 6.3 2区医学 Q1 CLINICAL NEUROLOGY

International Journal of Stroke Pub Date : 2024-08-01 Epub Date: 2024-03-16 DOI:10.1177/17474930241237120

Adel Alhazzani, Fahad S Alajlan, Ali M Alkhathaami, Fahmi Mohammed Al-Senani, Taim A Muayqil, Saeed A Alghamdi, Ammar AlKawi, Saeed AlZahrani, Majid Bakheet, Mohammed Aljohani, Nouran Taher, Abdulkarim Almutairi, Mustafa AlQarni, Sadiq Alsalman, Saeed A Alqahtani, Nouf Almansour, Laila Abukhamsin, Amr Mouminah, Nehal Almodarra, Gamal Mohamed, Meshal Almodhy, Eid Albogumi, Mohamad Alzawahmah, Abdulrahman Alreshaid, Naveed Akhtar, Muhammad Shazam Hussain, Gregory W Albers, Ashfaq Shuaib

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引用次数: 0

Abstract

Background: Following transient ischemic attack (TIA) and minor stroke, the risk of recurrent stroke can be significantly reduced with short-duration dual antiplatelet therapy (DAPT). We wish to investigate whether 10 days of DAPT is as effective as 21 days' treatment.

Study design: This is an open-label, randomized, parallel-group study comparing whether 10 days of DAPT treatment (ASA + clopidogrel) is non-inferior to 21 days of DAPT in patients with acute ischemic stroke (AIS) or high-risk TIA. In both groups, DAPT is started within 24 hours of symptom onset. This study is being conducted in approximately 15 study sites in the Kingdom of Saudi Arabia. The planned sample size is 1932.

Outcomes: Non-inferiority of 10 days compared to 21 days of DAPT in the prevention of the composite endpoint of stroke and death at 90 days in AIS/TIA patients. The primary safety outcome is major intra-cranial and systemic hemorrhage.

Study period: Enrolment started in the second quarter of 2023, and the completion of the study is expected in the fourth quarter of 2025.

Discussion: The trial is expected to show that 10 days of DAPT is non-inferior for the prevention of early recurrence of vascular events in patients with high-risk TIAs and minor strokes.

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在急诊室开始治疗时，缩短治疗时间对脑卒中和高危 TIAs 的疗效（SHORTER-研究）。

背景：TIA 和轻微卒中后，短期双联抗血小板疗法 (DAPT) 可显著降低卒中复发风险。我们希望研究 10 天的 DAPT 是否与 21 天的治疗同样有效：这是一项开放标签、随机、平行分组的研究，比较在轻微缺血性中风（AIS）或高危短暂性脑缺血发作（TIA）患者中，10 天的 DAPT 治疗（ASA+氯吡格雷）是否不劣于 21 天的 DAPT 治疗。两组患者均在症状出现 24 小时内开始使用 DAPT。这项研究正在沙特阿拉伯王国约 15 个研究地点进行。计划样本量为 1932 例：在预防 AIS/TIA 患者 90 天后中风和死亡的复合终点方面，10 天 DAPT 与 21 天 DAPT 相比无劣效性。主要安全性结果是颅内和全身大出血：研究期限：2023 年第二季度开始注册，预计 2025 年第四季度完成研究：该试验有望表明，10天的DAPT在预防高危TIA和轻微中风患者血管事件早期复发方面并无劣势。

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

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.