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Clinical Trials/NCT03259399
NCT03259399UnknownNot Applicable

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 site in 1 country2,200 target enrollmentStarted: August 16, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
2,200
Locations
1
Primary Endpoint
Incidence of dry cough

Study Overview

Brief Summary

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Other

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Incidence of dry cough

Time Frame: At 2 years

First Incidence of stroke

Time Frame: At 2 years

Secondary Outcomes

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

Investigators

Sponsor
Cui Yimin
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Cui Yimin

Director of pharmacy,M.D & Ph.D

Peking University First Hospital

Study Sites (1)

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