EUCTR2015-003731-35-NL进行中（未招募）1 期
A Randomized Double-blind Placebo Controlled Study Characterizing The Effects of PCSK9 Inhibition On Arterial Wall inflammation in Patients With Elevated Lp(a) - ANITSCHKOW
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Amgen Inc
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Male or female, = 50 years of age at the time of informed consent
- •- Subject with fasting Lp(a) = 50 mg/dL at screening 1
- •- Subject with fasting LDL-C = 100 mg/dL at screening 1
- •- For those subjects receiving lipid lowering therapy, lipid-lowering therapy, including statin dose, must be unchanged for = 8 weeks prior to screening
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 84
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 36
排除标准
- •- Known diagnosis of diabetes mellitus or screening fasting serum glucose = 126 mg/dL or HbA1C = 6.5%
- •- A history of homozygous familial hypercholesterolemia
- •- Recent cardiovascular event within 3 months prior to randomization, or planned cardiac surgery, PCI or carotid stenting, or planned major non-cardiac surgery during the course of the study period
- •- Currently undergoing lipid apheresis
- •- Known contraindications or limitations to FDG-PET/ CT
- •- Auto-immune disease/vasculitis, active inflammatory diseases, proven or suspected bacterial infections. Recent (< 1 month prior to screening) or ongoing serious infection requiring intravenous antibiotic therapy
- •- Recent (< 6 weeks prior to screening) or current treatment with medications that may have a significant effect on plaque inflammation as measured by plaque TBR, including: oral, rectal, or injectable corticosteroids or immunosuppressive medications
- •- Recent (< 6 weeks prior to screening) or current treatment with aspirin (> 325 mg/day) or NSAIDs (> 1000 mg/day)
- •- Known sensitivity to any of the active substances or excipients to be administered during dosing
- •- Subject has taken a cholesterol ester transfer protein inhibitor or mipomersen or lomitapide in the last 12 months prior to screening
- •- Known systemic disorders or any clinically significant medical condition that could interfere with the conduct of the study
- •- History of malignancy (except non-melanoma skin cancers, cervical in-situ carcinoma, breast ductal carcinoma in situ, or stage 1 prostate carcinoma) within the last 5 years
- •- Subject has previously received evolocumab or any other therapy to inhibit PCSK9
研究者
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