Subjects With Hyperlipidemia, Dyslipidemia Clinical Trial
— ANITSCHKOWOfficial title:
A RaNdomized Double-blInd Placebo ConTrolled Study Characterizing THe Effects of PCSK9 Inhibition On Arterial Wall Inflammation in Patients With Elevated Lp(a) (ANITSCHKOW)
| Verified date | September 2022 |
| Source | Amgen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 129 |
| Est. completion date | April 5, 2018 |
| Est. primary completion date | April 5, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 50 Years to 80 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Research Site | Chicoutimi | Quebec |
| Canada | Research Site | Newmarket | Ontario |
| Canada | Research Site | Quebec | |
| Canada | Research Site | Toronto | Ontario |
| Netherlands | Research Site | Amsterdam | |
| Netherlands | Research Site | Apeldoorn | |
| Netherlands | Research Site | Nijmegen | |
| Netherlands | Research Site | Rotterdam | |
| Netherlands | Research Site | Venlo | |
| Netherlands | Research Site | Waalwijk | |
| United States | Research Site | Hurst | Texas |
| United States | Research Site | Las Vegas | Nevada |
| United States | Research Site | Miami | Florida |
| United States | Research Site | Mooresville | North Carolina |
| United States | Research Site | Philadelphia | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Amgen |
United States, Canada, Netherlands,
Stiekema LCA, Stroes ESG, Verweij SL, Kassahun H, Chen L, Wasserman SM, Sabatine MS, Mani V, Fayad ZA. Persistent arterial wall inflammation in patients with elevated lipoprotein(a) despite strong low-density lipoprotein cholesterol reduction by proprotein convertase subtilisin/kexin type 9 antibody treatment. Eur Heart J. 2019 Sep 1;40(33):2775-2781. doi: 10.1093/eurheartj/ehy862. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. |
Baseline and week 16 | |
| Secondary | Percent Change From Baseline in Lipoprotein(a) Concentration at Week 16 | Baseline and week 16 | ||
| Secondary | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Concentration at Week 16 | Baseline and week 16 | ||
| Secondary | Percent Change From Baseline in Apolipoprotein B Concentration at Week 16 | Baseline and week 16 |