Τίτλος:
Rationale and design of the effectiveness of lower maintenance dose of TicagRelor early after myocardial infarction (ELECTRA) pilot study
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
Aims 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. Methods and results 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. Conclusion 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. © 2017 The Author.
Συγγραφείς:
Kubica, J.
Adamski, P.
Buszko, K.
Kubica, A.
Kuliczkowski, W.
Fabiszak, T.
Jilma, B.
Alexopoulos, D.
Paciorek, P.
Navarese, E.P.
Περιοδικό:
EUROPEAN HEART JOURNAL-CARDIOVASCULAR PHARMACOTHERAPY
Εκδότης:
Oxford University Press
Λέξεις-κλειδιά:
ticagrelor; actin binding protein; antithrombocytic agent; biological marker; cell adhesion molecule; phosphoprotein; ticagrelor; vasodilator-stimulated phosphoprotein, acute heart infarction; adult; aged; Article; clinical article; controlled study; dose response; drug dose comparison; drug dose escalation; drug dose reduction; drug efficacy; dual antiplatelet therapy; female; human; liquid chromatography-mass spectrometry; loading drug dose; maintenance drug dose; male; metabolic regulation; open study; percutaneous coronary intervention; phase 3 clinical trial; pilot study; priority journal; randomized controlled trial; thrombocyte aggregation inhibition; thrombocyte function; treatment duration; blood; blood clotting parameters; comparative study; drug effect; drug monitoring; heart infarction; liquid chromatography; mass spectrometry; metabolism; mortality; phase 3 clinical trial (topic); Poland; procedures; randomized controlled trial (topic); thrombocyte; thrombocyte aggregation; treatment outcome, Biomarkers; Blood Platelets; Cell Adhesion Molecules; Chromatography, Liquid; Clinical Trials, Phase III as Topic; Drug Monitoring; Humans; Mass Spectrometry; Microfilament Proteins; Myocardial Infarction; Percutaneous Coronary Intervention; Phosphoproteins; Pilot Projects; Platelet Aggregation; Platelet Aggregation Inhibitors; Platelet Function Tests; Poland; Randomized Controlled Trials as Topic; Ticagrelor; Treatment Outcome
DOI:
10.1093/ehjcvp/pvx032
