Effects of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition on Arterial Wall Infl… (NCT02729025) | Clinical Trial Compass
CompletedPhase 3
Effects of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition on Arterial Wall Inflammation in Patients With Elevated Lipoprotein(a) (Lp(a))
United States129 participantsStarted 2016-04-14
Plain-language summary
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).
Who can participate
Age range50 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Percent Change From Baseline in Maximum Target-to-background Ratio in the Most Diseased Segment of the Index Vessel at Week 16