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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
129
Administered subcutaneously once a month using an autoinjector/pen.
Administered subcutaneously once a month using an autoinjector/pen.
Research Site
Miami, Florida, United States
Research Site
Las Vegas, Nevada, United States
Research Site
Mooresville, North Carolina, United States
Percent Change From Baseline in Maximum Target-to-background Ratio in the Most Diseased Segment of the Index Vessel at Week 16
Arterial inflammation was assessed using 18F-fluoro-deoxyglucose positron-emission tomography/computed tomography (18F-FDG PET/CT). Arterial 18F-FDG uptake is correlated with arterial macrophage content and predicts cardiovascular events. Images were analyzed by an experienced radiologist blinded to all patient characteristics. The maximum standardized uptake value was calculated as a time- and dose- corrected tissue radioactivity divided by body weight in the index and the target-to-background ratio (TBR) was calculated from the ratio of the standardized uptake value of the artery compared to mean background venous activity. The average maximum TBR for the most diseased segment (MDS) was calculated from a group of 3 contiguous slices (approximately 1.5 cm), centered on the slice with the highest maximum TBR in the index vessel. The index vessel was defined as the vessel (either the right or left carotid or aorta) with the highest mean TBR at baseline.
Time frame: Baseline and week 16
Percent Change From Baseline in Lipoprotein(a) Concentration at Week 16
Time frame: Baseline and week 16
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Concentration at Week 16
Time frame: Baseline and week 16
Percent Change From Baseline in Apolipoprotein B Concentration at Week 16
Time frame: Baseline and week 16
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Hurst, Texas, United States
Research Site
Newmarket, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Chicoutimi, Quebec, Canada
Research Site
Québec, Quebec, Canada
Research Site
Amsterdam, Netherlands
...and 5 more locations