Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Sun Yat-sen University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Until very recently, warfarin is still the best drug of choice for long-term anticoagulation for patients with mechanical prosthetic heart valve. However, the complication of warfarin account for 75 percent of the whole complication after the mechanical prosthetic heart valve replacement.
Interindividual variation in warfarin dose is mediated by multiple factors.Advanced models using combinations of clinical attributes and genetic factors(CYP2C9, VKORC1, and CYP4F2) explain 50-75% of variability in warfarin dose requirements.These warfarin dosing models have the potential to improve patient safety by reducing or eliminating serious adverse events. The investigators conducted a prospective, randomized, blinded, two arm trial to test this hypothesis.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Genotype-based Warfarin Initiation | Experimental |
| |
| clinical factor-based warfarin initiation | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Genotype-based Warfarin Initiation model | Other | Based on previous retrospective study,investigators established a genotype-based warfarin model to estimate the drug dosage. |
|
| Measure | Description | Time Frame |
|---|---|---|
| time to steady dosage | from seven days after the operation to thirty days after the operation | |
| Time in Therapeutic Range | from five days after the operation to thirty days after the operation |
| Measure | Description | Time Frame |
|---|---|---|
| first time to treatment window | from five days after the operation to thirty days after the operation | |
| the ratio of INR≥3.0 and INR≤1.5 | from five days after the operation to thirty days after the operation |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xi Zhang, MD. | Contact | 86-13902279690 | zhangxisysu@163.com | |
| Zhe Xu, MD.,PHD. | Contact | 86-13828453339 | xuzhesums@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xi Zhang, MD. | First Affiliated Hospital, Sun Yat-Sen University | Study Director |
| Zhe Xu, MD.,PHD. | First Affiliated Hospital, Sun Yat-Sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first affiliated hospital of Sun Yat Sen University | Recruiting | Guangzhou | Guangdong | 510080 | China |
Not provided
| Label | URL |
|---|---|
| one of the best warfarin dose model | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006470 | Hemorrhage |
| C564393 | Vitamin K-Dependent Clotting Factors, Combined Deficiency Of, Type 2 |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| clinical factor-based warfarin initiation model | Other | Based on previous retrospective study,investigators established a clinical factor-based warfarin model to estimate the drug dosage. |
|
| the monitoring frequency of INR | 30 days after the operation |
| the whole-cause mortality | 30 days after the operation |
| major bleeding event | 30 days after the operation |
| major thrombosis rate | 30 days after the operation |
| absolute difference between the stable dose and initial dose | 30 days after the operation |
| the frequency of dosage change | 30 days after the operation |