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



Status:Completed
Conditions:High Cholesterol
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:50 - 80
Updated:4/21/2018
Start Date:April 14, 2016
End Date:April 5, 2018

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A RaNdomized Double-blInd Placebo ConTrolled Study Characterizing THe Effects of PCSK9 Inhibition On Arterial Wall Inflammation in Patients With Elevated Lp(a) (ANITSCHKOW)

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).


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.
We found this trial at
6
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Newmarket,
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Hurst, TX
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Mooresville, North Carolina 28117
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Philadelphia, PA
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