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

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 (>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.

• Authors: Hiromasa Otake, Yoichiro Sugizaki, Takayoshi Toba, Yuichiro Nagano, Yoshiro Tsukiyama, Ken-Ichi Yanaka, Hiroyuki Yamamoto, Akira Nagasawa, Hiroyuki Onishi, Ryo Takeshige, Shinsuke Nakano, Yoichiro Matsuoka, Kosuke Tanimura, Hiroyuki Kawamori, Toshiro Shinke, Ken-Ichi Hirata
• Journal: Journal of cardiology (J Cardiol) Vol. 73 Issue 3 Pg. 228-232 (03 2019) ISSN: 1876-4738 [Electronic] Netherlands
• PMID: 30579806 (Publication Type: Clinical Trial Protocol, Journal Article)
• Copyright: Copyright © 2018 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.

Chemical References

• Antibodies, Monoclonal, Humanized
• Anticholesteremic Agents
• Cholesterol, LDL
• Hydroxymethylglutaryl-CoA Reductase Inhibitors
• Rosuvastatin Calcium
• alirocumab

Topics

• Adult
• Antibodies, Monoclonal, Humanized (administration & dosage)
• Anticholesteremic Agents (administration & dosage)
• Cholesterol, LDL (blood)
• Coronary Artery Disease (complications, diagnostic imaging, drug therapy)
• Drug Therapy, Combination
• Female
• Humans
• Hydroxymethylglutaryl-CoA Reductase Inhibitors (administration & dosage)
• Japan
• Male
• Middle Aged
• Percutaneous Coronary Intervention
• Plaque, Atherosclerotic (complications, diagnostic imaging, drug therapy)
• Postoperative Period
• Randomized Controlled Trials as Topic
• Rosuvastatin Calcium (administration & dosage)
• Tomography, Optical Coherence
• Treatment Outcome