Impact of Biomarkers on Pharmacokinetics and Pharmacodynamics of Direct Oral Anticoagulants

  • STATUS
    Recruiting
  • End date
    Dec 28, 2021
  • participants needed
    1200
  • sponsor
    Cui Yimin
Updated on 28 January 2021

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.

Details
Condition Pharmacokinetics, pharmacodynamic aspects, Pharmacokinetic aspects, Pharmacogenetics, Accurate Medication, Novel Oral Anticoagulants, NOACs, Rivaroxaban, Apixaban, Dabigatran
Treatment detection of genotype
Clinical Study IdentifierNCT03161496
SponsorCui Yimin
Last Modified on28 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Novel Oral Anticoagulants or Apixaban or Pharmacogenetics or Pharmacokinetic aspects or Pharmacokinetics or NOACs or Rivaroxaban or Dabigatran or phar...?
Do you have any of these conditions: Dabigatran or Accurate Medication or Pharmacogenetics or Pharmacokinetics or Apixaban or Pharmacokinetic aspects or Novel Oral Anticoagulants or NOACs...?
Do you have any of these conditions: Accurate Medication or NOACs or Rivaroxaban or Novel Oral Anticoagulants or Dabigatran or Pharmacokinetic aspects or Pharmacogenetics or Apixaban or P...?
Do you have any of these conditions: Novel Oral Anticoagulants or Pharmacogenetics or Accurate Medication or NOACs or Rivaroxaban or Dabigatran or pharmacodynamic aspects or Pharmacokinet...?
(I)Chinese Healthy Volunteers
In accordance with the inclusion criteria for each bioequivalence trial of NOACs
Sign informed consent of the research
Complete to collect indexes of pharmacodynamics and pharmacogenomics in the cycle with control drug
(II)Chinese Patients
In accordance with anticoagulation indications of NOACs, include prevention of thrombosis in non valvular atrial fibrillation, prevention and treatment of deep vein thrombosis / pulmonary embolism and prevention of thrombosis after knee / hip replacement
More than 18 years of age, male or female
Never received NOACs in a month and intend to take NOACs or have received NOACs for more than one week continuously
sign informed consent

Exclusion Criteria

(I)Chinese Healthy Volunteers
In accordance with the exclusion criteria for each bioequivalence trial of NOACs
(II)Chinese Patients
With history of immunodeficiency disease, including positive HIV index
Positive Hepatitis B surface antigen (HBsAg) and HCV index
Combined therapy of CYP3A4 strong inhibitors and P-gp inhibitors (e.g., systemic pyrrole antifungal agents such as ketoconazole, itraconazole, voriconazole and posaconazole; human immunodeficiency virus (HIV) - protease inhibitors such as ritonavir), CYP3A4 strong inducers and P-gp inducers (e.g., rifampicin, phenytoin, phenobarbital, carbamazepine, St. John's Wort, etc.) in 14 days before treatment with NOACs
Severe liver dysfunction and abnormal renal function
Include contraindications of NOACs, such as hypersensitivity, active bleeding, moderate or severe liver disease, previous history of intracranial hemorrhage, gastrointestinal hemorrhage in the past 6 months and major operation within 30 days
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