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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gene-directed group | Experimental | 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 |
|
| Standard care group | Active Comparator | the first day given 4.5mg; adjusted dose based on INR from the second day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gene-directed dosage of warfarin | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at Day90 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at Day28 |
| Time of the first time of the target INR |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 90 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lu Hua, MD. PhD | Thrombosis and Vascular Medicine Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese Academy of Medical Sciences Fuwai Hospital | Beijing | Beijing Municipality | 100037 | China |
Consent for sharing of non identifiable study data for regulatory authorities.
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D006349 | Heart Valve Diseases |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| standard dosage of warfarin | Other | the first day given 4.5mg; adjusted dose based on INR from the second day |
|
Time of the first time for participants to reach the target INR will be collected and reported during the study. |
| 90 days |
| D013568 |
| Pathological Conditions, Signs and Symptoms |