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临床试验/NCT03259399
NCT03259399Unknown不适用

A Study of Genetic Variants Associated With Enalapril-Induced Adverse Drug Reaction and Impact of Pharmacogenomics on First Stroke in Hypertensive Patients Taking Enalapril or Enalapril-Folic Acid Therapy.

Cui Yimin1 个研究点 分布在 1 个国家目标入组 2,200 人开始时间: 2017年8月16日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
2,200
试验地点
1
主要终点
Incidence of dry cough

研究概览

简要总结

Dry cough is the most common adverse reaction of angiotensin converting enzyme, including enalapril, in Chinese population. Clinical observations suggest that the incidence of ACEI-induced dry cough is different between Chinese and other racial groups, however, there is still lack of research data in Chinese. Stroke is the second leading cause of death in the world and leading cause of death in China. Except the known risk factor such as hypertension, high homocysteine level, folic acid deficiency, the impact of genetics should not be ignored.

In this study, we will investigate whether there are specific genotypes which may predict the incidence of (1)enalapril-induced dry cough in Chinese and (2)first stroke in hypertensive patients taking enalapril or enalapril-folic acid therapy, so as to provide a basis for developing guidelines on precision medication in enalapril therapy apply to Chinese population.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

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

入选标准

  • •Patients taking enalapril or enalapril-folic acid therapy
  • •Signed informed consent.

排除标准

  • •Patients not taking enalapril treated
  • •Intolerance or unwillingness to blood sample collection.

结局指标

主要结局

Incidence of dry cough

时间窗: At 2 years

First Incidence of stroke

时间窗: At 2 years

次要结局

  • Genotype detected by next generation sequencing(pre-dose of enalapril or enalapril-folic acid (Baseline))

研究者

发起方
Cui Yimin
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Cui Yimin

Director of pharmacy,M.D & Ph.D

Peking University First Hospital

研究点 (1)

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