Papers

Peer-reviewed International journal
Mar, 2019

Efficacy of alirocumab for reducing plaque vulnerability: Study protocol for ALTAIR, a randomized controlled trial in Japanese patients with coronary artery disease receiving rosuvastatin

J Cardiol
  • Otake Hiromasa
  • Sugizaki Y
  • Toba T
  • Nagano Y
  • Tsukiyama Y
  • Yanaka KI
  • Yamamoto H
  • Nagasawa A
  • Onishi H
  • Takeshige R
  • Nakano S
  • Matsuoka Y
  • Tanimura K
  • Kawamori Hiroyuki
  • Shinke T
  • Hirata Ken-ichi
  • Display all

Volume
73
Number
3
First page
228
Last page
232
Language
English
Publishing type
Research paper (scientific journal)
DOI
10.1016/j.jjcc.2018.11.012

BACKGROUND: Although a recent clinical trial demonstrated that alirocumab, a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, significantly reduces the incidence of acute coronary events, the impact of alirocumab on plaque stabilization remains uncertain. The Efficacy of ALirocumab for Thin-cap fibroatheroma in patients with coronary Artery disease estImated by optical coherence tomogRaphy (ALTAIR) study will investigate the effect of alirocumab on thin-cap fibroatheroma (TCFA) in Japanese patients who underwent recent percutaneous coronary intervention (PCI). METHODS AND DESIGN: ALTAIR is a phase IV, open-label, randomized, parallel-group, single-center study involving blinded optical coherence tomography (OCT) image analysis in Japanese adults hospitalized for PCI and having suboptimal control of low-density lipoprotein cholesterol (LDL-C) levels (>70mg/dL) despite statin therapy. Patients will be randomized (1:1) to the alirocumab arm (alirocumab 75mg every 2 weeks added to rosuvastatin 10mg/day) or the standard-of-care arm (rosuvastatin 10mg/day, with initiation and/or dose adjustment of non-statin lipid-lowering to achieve an LDL-C target of <70mg/dL). OCT imaging will be conducted at baseline and at week 36 (post-treatment). The primary objective is to compare the alirocumab and standard-of-care arms regarding the change in TCFA fibrous-cap thickness after 9 months of treatment. CONCLUSION: The outcomes of ALTAIR (ClinicalTrials.gov identifier: NCT03552432) will provide insights into the effect of alirocumab on plaque vulnerability following PCI in patients with suboptimal LDL-C control despite stable statin therapy.

Link information
DOI
https://doi.org/10.1016/j.jjcc.2018.11.012
PubMed
https://www.ncbi.nlm.nih.gov/pubmed/30579806
ID information
  • DOI : 10.1016/j.jjcc.2018.11.012
  • Pubmed ID : 30579806

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