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

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ClinicalTrials.gov Identifier: NCT02729025
Recruitment Status : Completed
First Posted : April 6, 2016
Results First Posted : April 23, 2019
Last Update Posted : April 23, 2019
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Subjects With Hyperlipidemia, Dyslipidemia Drug: Evolocumab Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official 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)
Actual Study Start Date : April 14, 2016
Actual Primary Completion Date : April 5, 2018
Actual Study Completion Date : April 5, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Evolocumab

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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02729025


Locations
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United States, Florida
Research Site
Miami, Florida, United States, 33144
United States, Nevada
Research Site
Las Vegas, Nevada, United States, 89118
United States, North Carolina
Research Site
Mooresville, North Carolina, United States, 28117
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States, 19141
United States, Texas
Research Site
Hurst, Texas, United States, 76054
Canada, Ontario
Research Site
Newmarket, Ontario, Canada, L3Y 5G8
Research Site
Toronto, Ontario, Canada, M9V 4B4
Canada, Quebec
Research Site
Chicoutimi, Quebec, Canada, G7H 7K9
Canada
Research Site
Quebec, Canada, G1V 4W2
Netherlands
Research Site
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
Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
  Study Documents (Full-Text)

Documents provided by Amgen:
Study Protocol  [PDF] February 8, 2017
Statistical Analysis Plan  [PDF] February 26, 2018

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02729025    
Other Study ID Numbers: 20130293
2015-003731-35 ( EudraCT Number )
First Posted: April 6, 2016    Key Record Dates
Results First Posted: April 23, 2019
Last Update Posted: April 23, 2019
Last Verified: March 2019
Keywords provided by Amgen:
Hyperlipidemia
Dyslipidemia
Proprotein convertase subtilisin/kexin type 9 (PCSK9) Inhibition
Arterial Wall Inflamation
Elevated lipoprotein a
Additional relevant MeSH terms:
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Dyslipidemias
Hyperlipidemias
Hyperlipoproteinemias
Inflammation
Pathologic Processes
Lipid Metabolism Disorders
Metabolic Diseases
Evolocumab
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents