ACTRN12617000401358已完成2 期
Mechanism of the Effect of Alirocumab on Lipoprotein(a) Metabolism in Subjects with Inherited Elevation in Lipoprotein(a)
inear Clinical Research Ltd.0 个研究点目标入组 21 人开始时间: 2017年3月17日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 21
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
入选标准
- •1.Caucasian and non-caucasian
- •2.Aged 18-75 years inclusive, male or female
- •3.Men and women on maximally tolerated high potency stains with elevated plasma Lp(a) concentrations [equal or more than 0.6 g/L] who have moderate-to-high cardiovascular disease (CVD) risk based on the Australian National Vascular Disease Prevention Alliance (NVDPA) Guidelines for management of absolute cardiovascular disease risk (including documented and/or family history of CVD or CVD risk equivalent including documented history of other clinical atherosclerotic disease(s) i.e. peripheral artery disease, clinically significant carotid artery disease, abdominal aortic aneurysm)
- •For the purposes of this project, documented CVD includes: documentation of a history of myocardial infarction [MI], coronary artery bypass graft surgery, percutaneous transluminal coronary angioplasty, or alternative revascularization procedure [e.g. atherectomy/stent], coronary artery disease documented by exercise or non-exercise stress test and/or clinically significant carotid artery disease documented by angiography, carotid ultrasonography, or any other accepted cardiac computed imaging technique
- •4.Participants will be of stable weight and maintaining a guideline recommended heart healthy diet (lower saturated fat, higher complex carbohydrate and lower salt content)
- •5.Participants will be on concurrent aspirin therapy, 75 mg – 300 mg orally once daily, for at least one week prior to Day 1 and continue for the duration of the study
排除标准
- •1.Cardiovascular events in the past 6-months
- •2.History of venous thromboembolism and/or pulmonary embolism
- •3.Low-density lipoprotein cholesterol equal to or less than 1.0 mmol/L
- •4.Participation in another clinical trial involving a PCSK9 monoclonal antibody
- •5.Type 1 Diabetes Mellitus
- •6.Type 2 Diabetes Mellitus
- •7.Secondary hyperlipidaemia
- •8.Renal disease (creatinine >130 micro mol/L, including proteinuria, nephrotic syndrome)
- •9.Hepatic dysfunction (AST or ALT > 5x ULN)
- •10.Current anaemia or past history of significant anaemia e.g. haemolytic anaemia (Hb must be >125 g/L to be eligible)
- •11.Haematological disorders
- •12.Recent history of haemorrhage or donation of blood within the 3 months prior to screening
- •13.Women who are on hormone replacement therapy
- •14.Positive laboratory screening result for HIV, Hepatitis B or C
- •15.Current smoker
- •16.Psychiatric illness (participants who are stable on treatment for depression or anxiety are eligible)
- •17.Alcohol excess (>30 g/day)
- •18.Hypersensitivity or contraindicating co-morbidities to Aspirin
- •19.Lipid-lowering therapies that are known to have major effects on plasma Lp(a) levels e.g. niacin, high dose fish oils (equal or more than 4 g/day)
- •20.Active auto-immune or vasculitic disorders
- •21.Likelihood of not completing the study as per judgement of investigator
- •22.Of Japanese and South East Asian decent
- •23.Women who are pregnant and / or not using a highly effective method of contraception
- •24.People highly dependent on medical care (i.e. unstable clinical status requiring frequent ambulatory or inpatient care)
- •25.People with a cognitive impairment, an intellectual disability or a mental illness
- •26.People whose primary language is other than English (LOTE) who will not be able to provide informed consent
- •27.Known hypersensitivity to monoclonal antibody or any component of the drug product
- •28.Donated blood within 3 months prior to Day 1
研究者
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