A Trial of Genotype-based Warfarin Initiation in Patients With Mechanical Prosthetic Heart Valve
NCT ID: NCT01633957
Last Updated: 2016-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2012-06-30
2016-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Genotype-based Warfarin Initiation
Genotype-based Warfarin Initiation model
Based on previous retrospective study,investigators established a genotype-based warfarin model to estimate the drug dosage.
clinical factor-based warfarin initiation
clinical factor-based warfarin initiation model
Based on previous retrospective study,investigators established a clinical factor-based warfarin model to estimate the drug dosage.
Interventions
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Genotype-based Warfarin Initiation model
Based on previous retrospective study,investigators established a genotype-based warfarin model to estimate the drug dosage.
clinical factor-based warfarin initiation model
Based on previous retrospective study,investigators established a clinical factor-based warfarin model to estimate the drug dosage.
Eligibility Criteria
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Inclusion Criteria
* willing to join in the clinical trial and comply with the protocol.
Exclusion Criteria
* previously receive any other cardiac surgery
* emergent surgery
* simultaneously carry out other cardiac surgeries,such as CABG
* age younger than 18y or older than 65 year
* drug abuser and wine abuser
* any malignancy
* moderate or severe hepatic or kidney insufficiency
* any thyroid disease
* the history of warfarin or VitK consumption 2 week before the surgery
* any hematological disease or history of bleeding
* combination with any drugs that significantly influence warfarin other than Cordarone
* pregnancy
* any contraindication of warfarin
* infectious endocarditis
* advanced valvular disease
* pathological obesity
* psychological disease
* any patient having joined in other clinical trial in the previous 30d
* basic INR \> 1.4
18 Years
65 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Xi Zhang
OTHER
Responsible Party
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Xi Zhang
Head of cardiac surgery
Principal Investigators
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Xi Zhang, MD.
Role: STUDY_DIRECTOR
First Affiliated Hospital, Sun Yat-Sen University
Zhe Xu, MD.,PHD.
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital, Sun Yat-Sen University
Locations
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The first affiliated hospital of Sun Yat Sen University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Related Links
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one of the best warfarin dose model
Other Identifiers
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SYSU-XZ001
Identifier Type: -
Identifier Source: org_study_id
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