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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-14

Study Completion Date

2018-04-05

Brief Summary

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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).

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Detailed Description

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Conditions

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Subjects With Hyperlipidemia, Dyslipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered subcutaneously once a month using an autoinjector/pen.

Evolocumab 420 mg QM

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

Group Type EXPERIMENTAL

Evolocumab

Intervention Type DRUG

Administered subcutaneously once a month using an autoinjector/pen.

Interventions

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Evolocumab

Administered subcutaneously once a month using an autoinjector/pen.

Intervention Type DRUG

Placebo

Administered subcutaneously once a month using an autoinjector/pen.

Intervention Type DRUG

Other Intervention Names

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Repatha AMG 145

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No