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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
200
Based on previous retrospective study,investigators established a genotype-based warfarin model to estimate the drug dosage.
Based on previous retrospective study,investigators established a clinical factor-based warfarin model to estimate the drug dosage.
The first affiliated hospital of Sun Yat Sen University
Guangzhou, Guangdong, China
RECRUITINGtime to steady dosage
Time frame: from seven days after the operation to thirty days after the operation
Time in Therapeutic Range
Time frame: from five days after the operation to thirty days after the operation
first time to treatment window
Time frame: from five days after the operation to thirty days after the operation
the ratio of INR≥3.0 and INR≤1.5
Time frame: from five days after the operation to thirty days after the operation
the monitoring frequency of INR
Time frame: 30 days after the operation
the whole-cause mortality
Time frame: 30 days after the operation
major bleeding event
Time frame: 30 days after the operation
major thrombosis rate
Time frame: 30 days after the operation
absolute difference between the stable dose and initial dose
Time frame: 30 days after the operation
the frequency of dosage change
Time frame: 30 days after the operation
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