Efficacy of alirocumab for reducing plaque vulnerability: Study protocol for ALTAIR, a randomized controlled trial in Japanese patients with coronary artery disease receiving rosuvastatin. Issue 3 (March 2019)

• Record Type: Journal Article
• Authors: Otake, Hiromasa; Sugizaki, Yoichiro; Toba, Takayoshi; Nagano, Yuichiro; Tsukiyama, Yoshiro; Yanaka, Ken-ichi; Yamamoto, Hiroyuki; Nagasawa, Akira; Onishi, Hiroyuki; Takeshige, Ryo; Nakano, Shinsuke; Matsuoka, Yoichiro; Tanimura, Kosuke; Kawamori, Hiroyuki; Shinke, Toshiro; Hirata, Ken-ichi
• Is Part Of: Journal of cardiology. Volume 73:Issue 3(2019)
• Page Start: 228
• Page End: 232
• Publication Date: 2019-03
• Subjects: Alirocumab -- Rosuvastatin -- Coronary artery disease -- Percutaneous coronary intervention; Cardiology -- Periodicals; 616.12
• DOI: 10.1016/j.jjcc.2018.11.012
• Languages: English
• ISSNs: 0914-5087

Abstract

Highlights: ALTAIR: Phase IV, open-label, randomized, parallel-group, single-center study. Alirocumab arm: alirocumab 75 mg every 2 weeks added to rosuvastatin 10 mg/day. Standard-of-care arm: rosuvastatin 10 mg/day. Optical coherence tomography (OCT) imaging at baseline and at week 36 (post-treatment). Main outcome measure: change in thickness of the fibrous cap (blinded OCT analysis). Abstract: 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 (>70 mg/dL) despite statin therapy. Patients will be randomized (1:1) to the alirocumab arm (alirocumab 75 mg every 2 weeks added to rosuvastatin 10 mg/day) or the standard-of-care arm (rosuvastatin 10 mg/day, with initiation and/or dose adjustment of non-statin lipid-lowering to achieve an LDL-C target of <70 mg/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.