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

Amgen

Status and phase: Completed; Phase 3

Conditions: Subjects With Hyperlipidemia, Dyslipidemia

Treatments: Drug: Placebo; Drug: Evolocumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02729025

2015-003731-35 (EudraCT Number)

20130293

Details and patient eligibility

About

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).

Enrollment: 129 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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129 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants received placebo to evolocumab by subcutaneous injection once a month (QM) for 12 weeks.

Treatment:

Drug: Placebo

Evolocumab 420 mg QM

Experimental group

Description:

Participants received 420 mg evolocumab by subcutaneous injection once a month (QM) for 12 weeks.

Treatment:

Drug: Evolocumab