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临床试验/NCT04921657
NCT04921657已完成不适用

Genome-wide Analysis of Lipid-lowering Efficacy and Drug Level of the Two Commonly Used Statins, Simvastatin and Rosuvastatin.

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 362 人开始时间: 2014年11月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
362
试验地点
1
主要终点
Genome-wide analysis of DNA sample

研究概览

简要总结

This study will perform a genome-wide association study (GWAS) of the lipid responses to rosuvastatin and simvastatin and plasma concentrations of these two statins in a homogeneous group of Han Chinese patients.

详细描述

A GWAS will be performed on about 360 Han Chinese patients with hypercholesterolaemia (which may be familial or non-familial) who have previously participated in a research project on the pharmacogenetics of statins and who have been treated with rosuvastatin and simvastatin to determine the genetic factors that may be related to the reduction in plasma low-density lipoprotein cholesterol (LDL-C) and plasma concentrations of these two statins. The lipid profiles were measured at baseline on no lipid-lowering treatment and after 4-6 week treatment of rosuvastatin 10 mg daily and after treatment with simvastatin 40 mg daily for at least 6 weeks with at least a 4-week washout period between the two treatments. Plasma concentrations of these two statins and their active metabolites about 12 hours after administration of statins have been measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS).

Genotyping for the whole-genome scan will be carried out on the Illumina OminiExpress beadchip (Illumina, San Diego, CA). The samples will be processed using the Illumina iScan platform at the Li Ka Shing Institute of Health Science, The Chinese University of Hong Kong (CUHK).

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of hypercholesterolemia (familial or non-familial)
  • Eligible for statin treatment according to local guidelines in the Hong Kong Public Hospital system.

排除标准

  • Taking other medication which may interact with the pharmacokinetics or lipid response to statins.
  • Not willing to cooperate with study requirements.

研究组 & 干预措施

Patients treated with statin.

Patients with hypercholesterolemia treated with rosuvastatin 10 mg daily or simvastatin 40 mg daily.

干预措施: Rosuvastatin 10mg (Drug)

结局指标

主要结局

Genome-wide analysis of DNA sample

时间窗: DNA samples taken after 4 weeks on statin treatment.

Presence or absence of single-nucleotide polymorphisms (SNPs) at over 700,000 points on the DNA samples will be analyzed using a whole-genome scan with the Illumina Omini Express BeadChip to identify which of these SNPs are associated with the LDL cholesterol reduction with rosuvastatin.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Brian Tomlinson

Professor

Chinese University of Hong Kong

研究点 (1)

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