Trials / Unknown
UnknownNCT03161496
Impact of Biomarkers on Pharmacokinetics and Pharmacodynamics of Direct Oral Anticoagulants
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,200 (estimated)
- Sponsor
- Cui Yimin · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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
| Type | Name | Description |
|---|---|---|
| GENETIC | detection of genotype | detection of genotype by next generation sequencing |
Timeline
- Start date
- 2017-06-06
- Primary completion
- 2021-10-01
- Completion
- 2021-12-01
- First posted
- 2017-05-19
- Last updated
- 2020-12-22
Locations
17 sites across 1 country: China
Source: ClinicalTrials.gov record NCT03161496. Inclusion in this directory is not an endorsement.