An interventional study of Gene-directed dosage of warfarin and standard dosage of warfarin in Atrial Fibrillation and Valvular Heart Disease, sponsored by China National Center for Cardiovascular Diseases. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-04-29.
Sponsored by China National Center for Cardiovascular Diseases · Not applicable, Interventional, and Treatment
To compare the efficiency and safety between gene-oriented group and standard care group during 90 days of initial warfarin-treatment for requiring anticoagulation patients with valve replacement or atrial fibrillation with or without valvular heart disease。
Due to narrow therapeutic window, and individual differences in dosage, inappropriate use of warfarin may lead to serious complications and ineffective. Based on the results of the research on the transformation of warfarin pharmacogenomics, this study investigates the clinical application of gene-directed warfarin dose prediction model through the preset dosage regimen of warfarin during the initial treatment phase. Compared with the conventional treatment, that is to say empirical medication, this study is to verify the feasibility and value of gene-oriented warfarin dose prediction model, in order to establish a practical guidance to optimize the rational use of warfarin treatment program, to enable patients to obtain effective, safe warfarin dose, and to achieve the established anticoagulant strength faster and safer, as the same time, to reduce the times of patients was blood and the incidence of bleeding/embolism, and to save costs and ensure the safety of warfarin clinical medication.
Exclusion Criteria:
the first day given model prediction dose \* 1.5 times（\<6mg）；the second day given model prediction dose；adjusted dose based on INR from the third day
Other: Gene-directed dosage of warfarin
the first day given 4.5mg; adjusted dose based on INR from the second day
Other: standard dosage of warfarin
the first day given model prediction dose \* 1.5 times（\<6mg）；the second day given model prediction dose；adjusted dose based on INR from the third day
the first day given 4.5mg; adjusted dose based on INR from the second day
therapeutic INR range (TTR) 90
The percentage of time in therapeutic INR range (TTR) using the number of INRs within the therapeutic range divided by the number of INRs collected, will be assessed at Day90, and the TTR of all patients will be reported.
Time frame: at Day90
therapeutic INR range (TTR) 28
The percentage of time in therapeutic INR range (TTR) using the number of INRs within the therapeutic range divided by the number of INRs collected, will be assessed at Day28, and the TTR of all patients will be reported.
Time frame: at Day28
Time of the first time of the target INR
Time of the first time for participants to reach the target INR will be collected and reported during the study.
Time frame: 90 days
thrombus or embolism or bleeding complications
The number of thrombus or embolism or any hemorrhage events for participants through the study completion will be collected and assessed at Day90.
Time frame: 90 days
Plan to share: No — Consent for sharing of non identifiable study data for regulatory authorities.
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China National Center for Cardiovascular Diseases