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

September 9, 2022 updated by: Amgen

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

129

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1V 4W2
        • Research Site
    • Ontario
      • Newmarket, Ontario, Canada, L3Y 5G8
        • Research Site
      • Toronto, Ontario, Canada, M9V 4B4
        • Research Site
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 7K9
        • Research Site
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Research Site
      • Apeldoorn, Netherlands, 7334 DZ
        • Research Site
      • Nijmegen, Netherlands, 6525 GA
        • Research Site
      • Rotterdam, Netherlands, 3015 CE
        • Research Site
      • Venlo, Netherlands, 5912 BL
        • Research Site
      • Waalwijk, Netherlands, 5141 BM
        • Research Site
  • United States
    • Florida
      • Miami, Florida, United States, 33144
        • Research Site
    • Nevada
      • Las Vegas, Nevada, United States, 89118
        • Research Site
    • North Carolina
      • Mooresville, North Carolina, United States, 28117
        • Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19141
        • Research Site
    • Texas
      • Hurst, Texas, United States, 76054
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Participants received placebo to evolocumab by subcutaneous injection once a month (QM) for 12 weeks.
Drug: Placebo
Administered subcutaneously once a month using an autoinjector/pen.
Experimental: Evolocumab 420 mg QM
Participants received 420 mg evolocumab by subcutaneous injection once a month (QM) for 12 weeks.
Drug: Evolocumab
Administered subcutaneously once a month using an autoinjector/pen.
Other Names:
  • Repatha
  • AMG 145

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and week 16

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent Change From Baseline in Lipoprotein(a) Concentration at Week 16
Time Frame: Baseline and week 16
Baseline and week 16
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Concentration at Week 16
Time Frame: Baseline and week 16
Baseline and week 16
Percent Change From Baseline in Apolipoprotein B Concentration at Week 16
Time Frame: Baseline and week 16
Baseline and week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2016

Primary Completion (Actual)

April 5, 2018

Study Completion (Actual)

April 5, 2018

Study Registration Dates

First Submitted

March 8, 2016

First Submitted That Met QC Criteria

March 31, 2016

First Posted (Estimate)

April 6, 2016

Study Record Updates

Last Update Posted (Actual)

September 23, 2022

Last Update Submitted That Met QC Criteria

September 9, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20130293
  • 2015-003731-35 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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