EUCTR2017-004299-69-ES进行中（未招募）1 期
ow interventional, open and multicentric clinical trial to evaluate the effect of alirocumab on volume, architecture and composition of atheroma plaque in patients with familial hypercholesterolemia from SAFEHEART registry. ARCHITECT study - ARCHITECT
Fundación Hipercolesterolemia Familiar0 个研究点目标入组 162 人开始时间: 2018年3月14日最近更新:
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
- 入组人数
- 162
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
- •- Signed informed consent before the beginning of specific trial procedures
- •- ;ail or female patients, aged between 35 and 65 years
- •- Patients with molecular diagnostic of Familial Hypercholesterolemia, enrolled on spanish registry SAFEHEART
- •- Asymptomatc patients
- •- Patients without previous history of clinical cardiovascular events (myocardial acute infarction, stroke, coronary revascularization...)
- •- Patiens receiving optimized and stable treatment with maximum tolerated doses of statins in combination or not with other lipid-lowering drugs during at least three months, with inappropiate control, defined by cLDL>100mg/dl
- •- Patiens with PAV > 30% on basal coronary ACT, carried out on the last three months before basal visit
- •- Patients with indication of alirocumab 150 mg/ml treatment, according to patient's characteristics and technical data sheet
- •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 162
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Class >II cardiac insufficiency according to NYHA scale (New York Heart Association)
- •- Cardiac Rhythm different to normal sinus rhythm (regular CF betwen 60-100 beat per min)
- •- Previous history of myocardial acute infarction, peripheral arterial thrombosis, stroke or transient ischemic attack
- •- Uncontrolled Hypertension, defined as systolic pressure value at rest >180mmHg at basal visit
- •- Fast triglycerides >250 mg/dl at baseline
- •- Type 1 or type 2 diabetes poorly controlled (HB1A>9%)
- •- History of hereditary muscular disorders
- •- Thyroid disease or thyroid hormone replacement therapy
- •- Glomerular filtration rate < 60 ml/min/1,73m2 at baseline
- •- High levels of AST and/or ALT (>3 ULN levels at baseline)
- •- High levels of creatinine kinase (>3 ULN at baseline)
- •- Patients that have been treated previously with IPCSK9, CETP inhibitors, mipomersen and/or lomitapide
- •- Statin-intolerant patients
- •- Active cancer disease or previous history of cancer
- •- Active clinically relevant infections or significative hematologycal, metabolic, gastrointestinal, endocrine or kidney dysfunction
- •- Availability of coronary angioCT at baseline that does not fulfill technical requisites for being processed with QAngio CT software
- •- Patients enrolled in clinical trials, except in case that study treatment has been discontinued more than 6 months before the beginning of the study
- •- Pregnant or lactating women, or fertile women that are not willing to use an appropiate anticonceptive method
研究者
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