PCSK9 Inhibition After Heart Transplantation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Change in volume of plaque at 1 year post study drug start post heart transplant
研究概览
简要总结
The focus of this study is to test the safety and efficacy of the PCSK9 inhibitor, alirocumab when administered early after heart transplantation (HT).The main objective of this project is to test the safety and impact on cardiac allograft vasculopathy (CAV) of alirocumab when given early after HT.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Heart Transplant recipient
排除标准
- •impaired liver function
研究组 & 干预措施
placebo
placebo to match alirocumab every other week for one year following start of study drug
干预措施: placebo (Biological)
alirocumab
alirocumab 150mg subcutaneous every other week for one year following start of study drug
干预措施: alirocumab (Biological)
结局指标
主要结局
Change in volume of plaque at 1 year post study drug start post heart transplant
时间窗: Baseline and one year
Measured change in coronary artery plaque volume(MM3), measured by Intravascular Ultrasound at time of coronary arteriogram within 4-8 weeks post transplant( baseline) and one year after study drug start post transplant
Plaque Volume
时间窗: Baseline to one year
Coronary artery plaque volume (mm³) was assessed using intravascular ultrasound (IVUS) during coronary angiography. Measurements were obtained at baseline (prior to study drug randomization) and at 1 year following treatment. The outcome measure represents the change in plaque volume from baseline to 1 year.
次要结局
- Change in LDL-C(Baseline, 3, 6 and 12 months)
- Change in lipoprotein (a)(Baseline, 3, 6 and 12)
- Change in apolipoprotein B(Baseline, 3, 6 and 12)
- Percent change in coronary vessel size by fractional flow reserve(baseline and one year)
- HDL Cholesterol(Baseline and one year)
- Low-Density Lipoprotein Cholesterol (LDL-C) Levels(Baseline and one year)
- Apolipoprotein B (ApoB)(Baseline and 1 year)
- Lipoprotein(a)(Baseline and 1 year)
- Total Cholesterol(Baseline and one year)
- Triglycerides(Baseline and one year)
- High-sensitivity C-reactive Protein (Hs-CRP)(Baseline and one year)
- Fractional Flow Reserve (FFR)(baseline and one year)
- Coronary Flow Reserve (CFR)(Baseline and 1 year)
- Index of Microcirculatory Resistance (IMR)(Baseline and 1 year)
- Lipid Core Burden Index (LCBI)(Baseline and 1 year)
- Maximum Lipid Core Burden Index in 4 mm (maxLCBI 4mm)(Baseline and 1 year)
- Maximum Intimal Thickness (MIT)(Baseline and 1 year)
研究者
William Fearon
Professor, Cardiovascular Medicine
Stanford University