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临床试验/NCT01450410
NCT01450410终止4 期

Efecto Del ácido nicotínico Sobre la composición de Las lipoproteínas de Alta Densidad (HDL) y la función Del Endotelio Arterial en Los Pacientes Con cardiopatía isquémica Prematura y Concentraciones Elevadas de Colesterol-HDL

Xavier Pinto Sala1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2012年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
发起方
入组人数
12
试验地点
1
主要终点
Apo A1 of HDL

研究概览

简要总结

Patients with premature ischemic heart disease (PIHD) and elevated levels of HDL-C present an altered composition of high-density lipoproteins (HDL) which is associated with a loss of their anti-atherogenic effects and of their arterial endothelium function.

Objectives: To analyse if the treatment with nicotinic acid (NA)/Laropiprant can correct the alterations of the HDL composition and endothelial function in patients with PIHD and elevated HDL-C.

Methods: A total of 46 subjects with PIHD who are stable in the 3 months prior to the Study, who continue in treatment with statins and have elevated concentrations of HDL-C (HDL-C ≥2.0mmol/L in females and ≥1.8mmol/L in males) and an LDL-C <100mg/dL. This is a double-blind, randomised Study; after 6 weeks of lifestyle stabilisation, the subjects will be treated with NA or placebo for 16 weeks. At the start and end of treatment, HDL composition will be studied through density gradient preparative ultracentrifuge separation and FBLC (fast protein liquid chromatography) and through the changes in vasodilation induced by the endothelium through ultrasound. Primary endpoint: change in the apoA1 content associated to treatment. Secondary endpoints: variations in the change of the brachial artery diameter with reactive hyperaemia and changes in the content of other lipid and protein components of HDL including apoA2, paraoxonase, amyloid A and LCAT. The changes in HDL composition and endothelial function will be assessed with an analysis of variance with repeated measurements and a 2x2 design.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
25 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Being male or female
  • Age > 25 years
  • Have an episode of ischemic heart disease before 55 years in men and in women 65 years
  • Serum HDL-C above the 90th percentile of the Spanish population: >=2.0mmol/L in women and >=1.8mmol/L in men (Gomez-Gerique JA, et al. Med Clin (Barc.). 1999, 113: 730-735.)
  • Stable treatment with any statin in the past 6 weeks: simvastatin, atorvastatin, rosuvastatin, pravastatin or lovastatin.

排除标准

  • Uncontrolled hypercholesterolemia or hypertriglyceridemia, LDL-C >2.6mmol/L or triglycerides >2.24mmol/L
  • Patients with an episode of ischemic heart disease in the last 3 months
  • Patients suffering from acute or chronic inflammatory diseases in the last 3 months
  • Treatment with fibrates or omega-3 fatty acids.
  • Treatment with steroids or immunosuppressive drugs
  • Patients with a contraindication to Tredaptive (Hypersensitivity to the active substances or any of the excipients, significant or unexplained hepatic dysfunction, active peptic ulcer, arterial bleeding).
  • Patients treated with drugs that may interact with Tredaptive (Midazolam).

研究组 & 干预措施

Nicotinic Acid

Active Comparator

干预措施: Nicotinic acid (Drug)

Placebo

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

Apo A1 of HDL

时间窗: Baseline; 12 weeks

The amount of Apo A1 as a marker of HDL composition.

次要结局

未报告次要终点

研究者

发起方
Xavier Pinto Sala
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Xavier Pinto Sala

Principal Investigator

Hospital Universitari de Bellvitge

研究点 (1)

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