Clareo Health | Effects of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition on Arterial Wall Inflammation in Patients With Elevated Lipoprotein(a) (Lp(a))
Effects of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition on Arterial Wall Inflammation in Patients With Elevated Lipoprotein(a) (Lp(a))
Saves the questions and what to expect into your notes, next to the visit they belong to.
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Lead
Amgen
Age
50–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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).
You may not be if
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