Heart Valve Prosthesis Clinical Trial
Official title:
Individualized Administration of Warfarin by Polymorphisms of VKORC1 and CYP2C9 Genes:A Randomized Controlled Trial, Multi-center Trial
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.
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.
Finally，according to the outcome parameters,statistical analysis were performed with SPSS
11.5 software. A value of P < 0.05 was considered statistically significant.
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