Faculty Information |
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Article types | Original article |
Language | English |
Refereed paper | Refereed |
Title | Randomized controlled trial of TY-51924, a novel hydrophilic NHE inhibitor, in acute myocardial infarction. |
Journal | Formal name:Journal of cardiology Abbreviation:J Cardiol ISSN code:1876-4738(Electronic)0914-5087(Linking) |
Volume, Number, Page | 67(4),pp.307-13 |
Papers・Author | Kimura Kazuo, Nakao Koichi, Shibata Yoshisato, Sone Takahito, Takayama Tadateru, Fukuzawa Shigeru, Nakama Yasuharu, Hirayama Haruo, Matsumoto Naoya, Kosuge Masami, Hiro Takafumi, Sakuma Hajime, Ishihara Masaharu, Asakura Masanori, Hamada Chikuma, Kaneko Akira, Yokoi Toshiaki, Hirayama Atsushi, Hirayama Atsushi |
Publication date | 2016/04 |
Papers・Description | BACKGROUND:In patients with ST-elevation acute myocardial infarction (STEMI), reperfusion therapy limits infarct size, but can directly evoke myocardial reperfusion injury. Activation of the Na(+)/H(+) exchanger (NHE) plays an important role in reperfusion injury. TY-51924, a novel NHE inhibitor, significantly reduced infarct size in animal studies and was well tolerated in early-phase clinical trials. This study aim was to evaluate the efficacy and safety of TY-51924 in patients with STEMI.METHODS:In this multicenter, randomized, double-blind, placebo-controlled Phase II trial, 105 patients with first anterior STEMI undergoing primary percutaneous coronary intervention (pPCI) were randomly assigned to receive an intravenous infusion of either TY-51924 or placebo. Primary endpoints were myocardial salvage index (MSI) as determined by single photon emission computed tomography (SPECT) 3-5 days after pPCI and safety up to 7 days.RESULTS:Baseline characteristics were similar in the two groups. MSI 3-5 days after pPCI (0.200 vs. 0.290, p=0.56), 3 months after pPCI (0.470 vs. 0.500, p=0.76), and the incidences of side effects did not differ between the two groups as a whole. However, on post hoc analysis of 52 patients with a large area at risk (AAR) (≥38%) and no antegrade coronary flow, MSI by SPECT at 3 months after pPCI was significantly higher in TY-51924 group (0.450 vs. 0.320, p=0.03). TY-51924 did not adversely influence hemodynamics.CONCLUSIONS:TY-51924 did not improve MSI or increase side effects as a whole. However, TY-51924 is potentially cardioprotective in the presence of a large AAR and no antegrade coronary flow. |
DOI | 10.1016/j.jjcc.2015.07.017 |
PMID | 26359711 |