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Sponsor ID
20130293

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

Sponsor ID
20130293
Clinicaltrials.gov ID
NCT02729025
EUCTIS ID
N/A
EudraCT ID
2015-003731-35
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Study Details

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).

Additional Study Details

Phase
Phase 3
Product
Evolocumab
Type
Interventional
Masking
Triple (Participant, Care Provider, Investigator)
Enrollment
129
Additional Study Details

Protocol Summary

Primary Outcome Measures

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

Timeframe: Week 16

Secondary Outcome Measures

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

Timeframe: Week 16

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

Timeframe: Week 16

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

Timeframe: Week 16

Locations

Location
Status
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Location
Research Site
Amsterdam, Netherlands, 1105 AZ
Status
Recruiting
Location
Research Site
Apeldoorn, Netherlands, 7334 DZ
Status
Recruiting
Location
Research Site
Nijmegen, Netherlands, 6525 GA
Status
Recruiting
Location
Research Site
Venlo, Netherlands, 5912 BL
Status
Recruiting
Location
Research Site
Waalwijk, Netherlands, 5141 BM
Status
Recruiting
Location
Research Site
Rotterdam, Netherlands, 3015 CE
Status
Recruiting
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Study Info
Age
50 - 80 Years
Condition
  • Heart, Blood & Circulatory - Other
    • Sex
    All
    Trial Dates
    Apr 2016 - Apr 2018
    Inclusion and Exclusion 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.