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 |
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).
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
sites
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