A Pharmacogenomics Study of Safety and Efficacy of Enalapril or Enalapril-Folic Acid Therapy in Hypertensive Patients.

Stroke Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03259399
• Other study ID #: 2016[1238]
• Status: Recruiting
• Start date: August 16, 2017
• Est. completion date: June 2020

Study information

• Verified date: August 2019
• Source: Peking University First Hospital
• Contact: Qian Xiang, Ph.D
• Phone: +86 010 66110802
• Email: xiangqz[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2200
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Enalapril Adverse Reaction
• Pharmacogenomics
• Stroke

Intervention

Genetic:
• detection of genotype
detection of genotype by next generation sequencing

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Cui Yimin

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of dry cough		At 2 years
Primary	First Incidence of stroke		At 2 years
Secondary	Genotype detected by next generation sequencing	Collect blood specimen before enalapril administration, then detect genotype of enalapril by next generation sequencing.	pre-dose of enalapril or enalapril-folic acid (Baseline)