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通过阿加曲班或坎格雷洛推注和输注联合替格瑞洛治疗 ST 段抬高型心肌梗死患者行直接经皮冠状动脉介入治疗:一项多中心随机开放标签试验(FABOLUS FASTER 试验):设计和原理

Facilitation Through Aggrastat or Cangrelor Bolus and Infusion Over PrasugreL: a MUlticenter Randomized Open-label Trial in PatientS with ST-elevation Myocardial InFarction Referred for PrimAry PercutaneouS InTERvention (FABOLUS FASTER) Trial: Design and Rationale : The FABOLUS FASTER Trial.

机构信息

Department of Cardiology, Bern University Hospital, CH-3010, Bern, Switzerland.

Department of Advanced Biomedical Sciences, Federico II University of Naples, Naples, Italy.

出版信息

J Cardiovasc Transl Res. 2021 Feb;14(1):110-119. doi: 10.1007/s12265-020-09969-4. Epub 2020 Feb 24.

Abstract

Antithrombotic therapy is a critical component of the management of ST-elevation myocardial infarction (STEMI) patients treated with primary percutaneous coronary intervention (PCI). Rapid and profound inhibition of platelet reactivity has been shown to mitigate the ischemic risks and improve myocardial salvage. High residual platelet reactivity (HRPR) has been reported up to 4 or 6 h after loading dose of prasugrel or ticagrelor; therefore, multiple alternative strategies, including crushed or chewed oral tables or intravenous agents, have been investigated to provide a more rapid and sustained inhibition of platelet function and bridge the initial treatment gap. The FABOLUS FASTER is the first investigator-initiated, multicentre, open-label, prospective, randomized study to directly compare the pharmacodynamics effects of cangrelor, tirofiban, chewed or integer prasugrel. This study will add new insights in the management of antiplatelet therapy in patients with STEMI undergoing primary PCI and might be hypothesis-generating for future clinical trials in this field. The trial is registered on clinicaltrials.gov NCT02978040, and EudraCT 2017-001065-24.

摘要

抗血栓治疗是接受直接经皮冠状动脉介入治疗 (PCI) 的 ST 段抬高型心肌梗死 (STEMI) 患者治疗的关键组成部分。快速而显著地抑制血小板反应性已被证明可降低缺血风险并改善心肌挽救。普拉格雷或替格瑞洛负荷剂量后高达 4 或 6 小时仍可观察到高残余血小板反应性 (HRPR);因此,已经研究了多种替代策略,包括将片剂压碎或嚼碎或使用静脉内药物,以提供更快速和持续的血小板功能抑制,并弥合初始治疗差距。FABOLUS FASTER 是首个由研究者发起的、多中心、开放性、前瞻性、随机研究,旨在直接比较坎格雷洛、替罗非班、嚼碎或整片普拉格雷的药效学作用。该研究将为 STEMI 患者接受直接 PCI 后的抗血小板治疗管理提供新的见解,并可能为该领域未来的临床试验提供假设。该试验在 clinicaltrials.gov 上注册为 NCT02978040,在 EudraCT 上注册为 2017-001065-24。

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