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Impact of Biomarkers on Pharmacokinetics and Pharmacodynamics of Direct Oral Anticoagulants

NCT03161496 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1200

Last updated 2020-12-22

No results posted yet for this study

Summary

It is general that there are many factors for individual differences of drugs in clinical application, of which genetic factors accounted for more than 20%. Novel oral anticoagulants-NOACs (include rivaroxaban, apixaban, dabigatran and so on) have advantages of convenient use and no need of monitoring, compared with the traditional vitamin K antagonist. With lack of predicted biomarkers, especially the research data of Chinese, it has the important significance in studying individual differences of NOACs in the anticoagulant efficacy and safety, through the pharmacogenomics research.

The aim of this study is to determine the polymorphism of drug metabolizing enzymes, drug transporters and drug target genes in Chinese population. By detecting the gene polymorphism, we intend to study the pharmacokinetic/ pharmacodynamics/ pharmacogenomics (PK-PD-PG) correlation of NOACs and provide scientific basis for accurate medication guide for people to use NOACs.

Conditions

  • Novel Oral Anticoagulants
  • NOACs
  • Rivaroxaban
  • Apixaban
  • Dabigatran
  • Pharmacokinetics
  • Pharmacodynamics
  • Pharmacogenomics
  • Accurate Medication

Interventions

GENETIC

detection of genotype

detection of genotype by next generation sequencing

Sponsors & Collaborators

  • Cui Yimin

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-06
Primary Completion
2021-10-31
Completion
2021-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03161496 on ClinicalTrials.gov