Chinese Academy of Medical Sciences Fuwai Hospital
Beijing, Beijing Municipality, 100037, China
NCT Number: NCT03479684
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。
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Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Beijing, Beijing Municipality, 100037, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
the first day given 4.5mg; adjusted dose based on INR from the second day
Time frame: at Day90
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 Day28
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: 90 days
Time of the first time for participants to reach the target INR will be collected and reported during the study.
Time frame: 90 days
The number of thrombus or embolism or any hemorrhage events for participants through the study completion will be collected and assessed at Day90.
China National Center for Cardiovascular Diseases
Other Gov
Randomized Trial of Genotype-guided Versus Standard for Warfarin Dosing
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