A RaNdomized Double-blInd Placebo ConTrolled Study Characterizing THe Effects of PCSK9 Inhibition On Arterial Wall Inflammation in Patients With Elevated Lp(a) (ANITSCHKOW)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 129
- 试验地点
- 1
- 主要终点
- Percent Change From Baseline in Maximum Target-to-background Ratio in the Most Diseased Segment of the Index Vessel at Week 16
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
Evolocumab 420 mg QM
Participants received 420 mg evolocumab by subcutaneous injection once a month (QM) for 12 weeks.
干预措施: Evolocumab (Drug)
Placebo
Participants received placebo to evolocumab by subcutaneous injection once a month (QM) for 12 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change From Baseline in Maximum Target-to-background Ratio in the Most Diseased Segment of the Index Vessel at Week 16
时间窗: Baseline and 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.
次要结局
- Percent Change From Baseline in Lipoprotein(a) Concentration at Week 16(Baseline and week 16)
- Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Concentration at Week 16(Baseline and week 16)
- Percent Change From Baseline in Apolipoprotein B Concentration at Week 16(Baseline and week 16)