Individualized Administration of Warfarin by Polymorphisms of VKORC1 and CYP2C9 Genes

  • STATUS
    Recruiting
  • End date
    Jan 1, 2023
  • participants needed
    600
  • sponsor
    Fujian Medical University
Updated on 22 January 2021

Summary

The purpose of this study is to explore the individualized administration model of warfarin suitable for Chinese people, and provide a scientific reference for the use of warfarin to Chinese people.

Description

About 600 patients with VKORC1 and CYP2C9 gene mutations were included in the treatment of warfarin anticoagulant therapy. The main indications include valve replacement, atrial fibrillation, pulmonary embolism, etc., randomly divided into 2 groups, respectively, the control group (that is, the use of fixed-dose group), Bayesian-model group, the use of single-blind treatment method, to evaluate the number of major adverse events, TTR and INR adjustments in patients between different groups after three months of taking warfarin, and then to explore the individualized drug use model of warfarin suitable for Chinese population.

In the Bayesian group, according to the genotype of VKORC1 and CYP2C9, the stable dose was calculated by the dose prediction model of Bayesian, and the first three drugs were taken at this dose, and then adjusted to the actual stable dose according to the change of INR. Meanwhile, the control group was administered according to the traditional way, that is, the initial dose is 2.5 or 3mg/d and is gradually adjusted to a stable dose according to changes of INR. The monitoring frequency of INR is: once a day from the beginning of the drug to the time of discharge, once a week after discharge, and once a month after the stable dose is obtained. Detailed records of the number of days to reach a stable dose, the INR value and the occurrence of side effects and time are documented. The concrete steps are as follows:

  1. clinicians to judge the standard of the selection criteria;
  2. to obtain the consent of the patient and sign an informed consent certificate;
  3. to collect 2ml anticoagulant blood before the drug, fill in the application form for individualized drug use in warfarin, and indicate the experimental group and control group;
  4. the specimen assigned to the laboratory for Genotyping;
  5. lab to calculate the predicted stable warfarin dose and the results fed back to the clinician within one working day after receiving the specimen;
  6. in the control group, the drug retained at the regular dose, and the first 3 days of the experimental group administered at the predicted dose;
  7. the dosage of warfarin in the two groups of cases adjusted to the stable dose according to the value, and the adjustment amplitude of the experimental group also referred to the predicted stable dose.
  8. to monitor INR once a day during hospitalization, and to those who do not receive a stable dose of discharge, follow up and monitor INR once a week until a stable dose or medication is obtained for 90 days;
  9. to document clinical trial records, including the daily use of warfarin, each detection of the appearance of the situation like INR value, bleeding, venous embolism and other side effects.

Finallyaccording to the outcome parameters,statistical analysis were performed with SPSS 11.5 software. A value of P < 0.05 was considered statistically significant.

Details
Condition Heart Valve Prosthesis
Treatment dose regime
Clinical Study IdentifierNCT03797534
SponsorFujian Medical University
Last Modified on22 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age > 14 years old
Warfarin anticoagulant therapy is required for at least 3 months
The genotype of patient VKORC1 is non-AA, CYP2C9 genotype is non _1/_ 1 the patients who are followed up, regularly monitored for INR and willing to provide peripheral blood for DNA extraction and genetic testing
The patient or family members can understand the research plan and will participate in this study and provide a written informed consent

Exclusion Criteria

Severe liver dysfunction (ChildPugh 10)
Severe infection, respiratory failure
Severe heart failure ( NYHA IV)
Severe renal insufficiency (Ccr 20ml / min)
Cancer
Diseases of the blood system
Severe pulmonary hypertension (PAPm 45mmHg)
Abnormal thyroid function
Patients with a history of venous thromboembolism, or serious events such as severe bleeding or embolism
Women who are pregnant or breastfeeding
Taking or planning to take other oral anticoagulants
The base INR value is >1.4
VKORC1, CYP2C9 genotypes are AA, _1/_ 1
Secondary valve replacement surgery
Emergency hospital admission for valve surgery
Diagnosis of coronary atherosclerotic heart disease
Severe mental illness, mental disorder ; -
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note