Department of Cardiology, Collegium Medicum, Nicolaus Copernicus University, 9 Sklodowskiej-Curie Street, 85-094 Bydgoszcz, Poland.
Department of Theoretical Foundations of Biomedical Science and Medical Informatics, Collegium Medicum, Nicolaus Copernicus University, 15 Jagiellonska Street, 85-067 Bydgoszcz, Poland.
Eur Heart J Cardiovasc Pharmacother. 2018 Jul 1;4(3):152-157. doi: 10.1093/ehjcvp/pvx032.
The degree and time course of platelet inhibition using ticagrelor can vary during the acute phase and the following stable period after acute myocardial infarction (AMI). The optimal level of platelet inhibition during the various stages of AMI remains an open question. The aim of the current study is to compare the antiplatelet efficacy of two ticagrelor maintenance dose regimens (60 mg b.i.d. vs. 90 mg b.i.d.) in stable patients following an initial strategy with ticagrelor 90 mg b.i.d. during the first month after AMI.
The Effectiveness of LowEr maintenanCe dose of TicagRelor early After myocardial infarction (ELECTRA) pilot study is a phase III, single-centre, randomized, open-label, pharmacokinetic/pharmacodynamic trial. The study population will include 50 patients with AMI treated with percutaneous coronary intervention. At Day 30 post-AMI, all trial participants will be randomly assigned in 1:1 ratio to receive either reduced (60 mg b.i.d.) or standard (90 mg b.i.d.) maintenance ticagrelor dose until Day 45 post-AMI. Platelet function testing in each patient will be performed using up to two different methods (the VASP assay and multiple electrode aggregometry). Pharmacokinetics of ticagrelor and its active metabolite (AR-C124910XX) will be assessed by liquid chromatography mass spectrometry.
A de-escalation strategy with reduced dose of ticagrelor (60 mg b.i.d.) following an initial standard dose (90 mg b.i.d.) during the first month after AMI may provide equally effective platelet inhibition as compared to maintenance with the standard ticagrelor dose.
CLINICALTRIALS. GOV IDENTIFIER: NCT03251859.
在急性心肌梗死（AMI）后的急性期和随后的稳定期，替格瑞洛的血小板抑制程度和时间进程可能会有所不同。AMI 各个阶段的最佳血小板抑制水平仍是一个悬而未决的问题。本研究旨在比较两种替格瑞洛维持剂量方案（60mg，每日两次[bid]与 90mg，每日两次[bid]）在初始替格瑞洛 90mg，每日两次治疗方案后，AMI 后第一个月内稳定患者中的抗血小板疗效。
低维持剂量替格瑞洛在心肌梗死后早期（ELECTRA）的有效性 pilot 研究是一项 III 期、单中心、随机、开放性、药代动力学/药效学试验。研究人群将包括 50 例接受经皮冠状动脉介入治疗的 AMI 患者。在 AMI 后 30 天，所有试验参与者将以 1:1 的比例随机分为接受降低（60mg，每日两次）或标准（90mg，每日两次）替格瑞洛维持剂量组，直至 AMI 后 45 天。每位患者的血小板功能检测将使用多达两种不同的方法（VASP 测定和多电极聚集测定）进行。替格瑞洛及其活性代谢物（AR-C124910XX）的药代动力学将通过液相色谱-质谱法进行评估。
与初始标准剂量（90mg，每日两次）相比，AMI 后第一个月内初始标准剂量（90mg，每日两次）后降低剂量（60mg，每日两次）的替格瑞洛递减策略可能提供同样有效的血小板抑制作用。
临床试验。gov 标识符：NCT03251859。
