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A Trial of Genotype-based Warfarin Initiation in Patients With Mechanical Prosthetic Heart Valve

NCT01633957 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2016-07-25

No results posted yet for this study

Summary

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.

Conditions

  • Anticoagulation Treatment Overdose
  • Heart Valve Diseases

Interventions

OTHER

Genotype-based Warfarin Initiation model

Based on previous retrospective study,investigators established a genotype-based warfarin model to estimate the drug dosage.

OTHER

clinical factor-based warfarin initiation model

Based on previous retrospective study,investigators established a clinical factor-based warfarin model to estimate the drug dosage.

Sponsors & Collaborators

  • Sun Yat-sen University

    collaborator OTHER

  • Xi Zhang

    lead OTHER

Principal Investigators

  • Xi Zhang, MD. · First Affiliated Hospital, Sun Yat-Sen University

  • Zhe Xu, MD.,PHD. · First Affiliated Hospital, Sun Yat-Sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01633957 on ClinicalTrials.gov