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Completed

NCT Number: NCT02729025

Effects of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition on Arterial Wall Inflammation in Patients With Elevated Lipoprotein(a) (Lp(a))

A study to assess the effects of proprotein convertase subtilisin/ kexin type 9 (PCSK9) inhibition on the arterial wall inflammation in patients with elevated lipoprotein(a).

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Key information

Conditions

Subjects With Hyperlipidemia, Dyslipidemia Behavior Dyslipidemias Hypercholesterolemia, Autosomal Dominant, 3 Hyperlipidemias Inhibition, Psychological Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Newmarket, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Fasting lipoprotein(a) (Lp(a)) 50 mg/dL or more at screening 1
  • Fasting Low-density lipoprotein-cholesterol (LDL-C) 100 mg/dL or more at screening 1
  • Lipid lowering therapy including statin dose unchanged for at least 8 weeks prior to screening
  • Target-to-background ratio (TBR) maximum higher than 1.6 (either right, left carotid or thoracic aorta) on fluorodeoxyglucose-positron emission tomography/computed tomography (FDG-PET/CT).

Exclusion criteria

  • Currently receiving, or less than 4 weeks since receiving, treatment in another investigational device or drug study(ies), or participating in other investigational procedures
  • Known diagnosis of diabetes mellitus or screening fasting serum glucose ≥ 126 mg/dL or hemoglobin A1C (HbA1C) ≥ 6.5%
  • Subject with a history of homozygous familial hypercholesterolemia
  • History of a Cardiovascular event
  • Subject currently undergoing lipid apheresis
  • Known contraindications or limitations to FDG-PET/ CT (scanner weight limit, devices that can cause image artifacts, or carotid/aortic stents/grafts
  • Subject has had exposure to investigational drugs targeting Lp(a) within the last 12 months, prior to Screening
  • Other Exclusion Criteria May Apply.

Treatment and study plan

Evolocumab

Drug

Administered subcutaneously once a month using an autoinjector/pen.

Other names: Repatha, AMG 145

Placebo

Drug

Administered subcutaneously once a month using an autoinjector/pen.

Primary outcomes

  1. Percent Change From Baseline in Maximum Target-to-background Ratio in the Most Diseased Segment of the Index Vessel at Week 16

    Time frame: Baseline and week 16

    Arterial inflammation was assessed using 18F-fluoro-deoxyglucose positron-emission tomography/computed tomography (18F-FDG PET/CT). Arterial 18F-FDG uptake is correlated with arterial macrophage content and predicts cardiovascular events. Images were analyzed by an experienced radiologist blinded to all patient characteristics.

    The maximum standardized uptake value was calculated as a time- and dose- corrected tissue radioactivity divided by body weight in the index and the target-to-background ratio (TBR) was calculated from the ratio of the standardized uptake value of the artery compared to mean background venous activity. The average maximum TBR for the most diseased segment (MDS) was calculated from a group of 3 contiguous slices (approximately 1.5 cm), centered on the slice with the highest maximum TBR in the index vessel. The index vessel was defined as the vessel (either the right or left carotid or aorta) with the highest mean TBR at baseline.

Secondary outcomes

  1. Percent Change From Baseline in Lipoprotein(a) Concentration at Week 16

    Time frame: Baseline and week 16

  2. Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Concentration at Week 16

    Time frame: Baseline and week 16

  3. Percent Change From Baseline in Apolipoprotein B Concentration at Week 16

    Time frame: Baseline and week 16

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

A RaNdomized Double-blInd Placebo ConTrolled Study Characterizing THe Effects of PCSK9 Inhibition On Arterial Wall Inflammation in Patients With Elevated Lp(a) (ANITSCHKOW)

Acronym: ANITSCHKOW

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 6, 2016
Registry last updated
Sep 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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