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Effects of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition on Arterial Wall Inflamation Study 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
Last Update Posted : April 19, 2018
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: Repatha (Evolocumab) Drug: Placebo Phase 3

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
Experimental: Repatha (Evolocumab)
Repatha (Evolocumab) subcutaneous injection every 4 weeks (QM) using 3 auto injector (AI) Pen
Drug: Repatha (Evolocumab)
Dose of subcutaneous Repatha (Evolocumab) every 4 weeks (QM) using 3 auto injector (AI) Pen

Placebo Comparator: Repatha (Evolocumab) Matching Placebo
Repatha (Evolocumab) Matching Placebo subcutaneous injection every 4 weeks (QM) using 3 auto injector (AI) Pen
Drug: Placebo
Dose of subcutaneous Repatha (Evolocumab) Matching Placebo every 4 weeks (QM) using 3 auto injector (AI) Pen




Primary Outcome Measures :
  1. Effect of Repatha (Evolocumab) on Lp(a), as measured by percent change from baseline at week 16 in target-to-background ratio of an index vessel by FDG-PET/CT in subjects with baseline Lp(a)>=50mg/dL and Low-density lipoprotein-cholesterol>=100mg/dL [ Time Frame: Week 16 ]
    The mentioned imaging method used will be fluorodeoxyglucose-positron emission tomography/ computed tomography (FDG-PET/CT);


Secondary Outcome Measures :
  1. Effect of Repatha (Evolocumab) on Lp(a), as measured by percent change in Lp(a) from baseline at week 16 in subjects with baseline Lp(a)>=50mg/dL and Low-density lipoprotein-cholesterol (LDL-C)>=100mg/dL [ Time Frame: Week 16 ]
  2. Effect of Repatha (Evolocumab) on LDL-C, as measured by percent change in LDL-C from baseline at week 16 in subjects with baseline Lp(a)>=50mg/dL and LDL-C>=100mg/dL [ Time Frame: Week 16 ]
  3. Effect of Repatha (Evolocumab) on Apolipoprotein B (ApoB), as measured by percent change in ApoB from baseline at week 16 in subjects with baseline Lp(a)>=50mg/dL and LDL-C>=100mg/dL [ Time Frame: Week 16 ]

Other Outcome Measures:
  1. Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events version 4 to Repatha (Evolocumab) in subjects with baseline Lp(a)>=50mg/dL and LDL-C>=100mg/dL [ Time Frame: Permanently throughout the study duration until EOS, an average of 1 year ]


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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)) 50mg/dL or more at screening 1
  • Fasting Low-density lipoprotein-cholesterol (LDL-C) 100mg/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) max 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
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
Study Director: MD Amgen

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02729025     History of Changes
Other Study ID Numbers: 20130293
2015-003731-35 ( EudraCT Number )
First Posted: April 6, 2016    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: April 2018

Keywords provided by Amgen:
Hyperlipidemia
Dyslipidemia
Proprotein convertase subtilisin/kexin type 9 (PCSK9) Inhibition
Arterial Wall Inflamation
Elevated lipoprotein a

Additional relevant MeSH terms:
Dyslipidemias
Hyperlipidemias
Hyperlipoproteinemias
Lipid Metabolism Disorders
Metabolic Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs