A Trial of Genotype-based Warfarin Initiation in Patients With Mechanical Prosthetic Heart Valve (SYSU-WARFA)

July 22, 2016 updated by: Xi Zhang

Academic Leader，Head of Cardiac Surgery,Principal Investigator, Clinical Professor

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • The First Affiliated Hospital of Sun Yat sen University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Zhe Xu, MD.PHD.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • the first time to receive elective mitral and/or aortic mechanical prosthetic valve replacement
  • willing to join in the clinical trial and comply with the protocol.

Exclusion Criteria:

  • other ethnic groups than Han
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Genotype-based Warfarin Initiation
Other: Genotype-based Warfarin Initiation model
Based on previous retrospective study,investigators established a genotype-based warfarin model to estimate the drug dosage.
Active Comparator: clinical factor-based warfarin initiation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
time to steady dosage
Time Frame: from seven days after the operation to thirty days after the operation
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
from five days after the operation to thirty days after the operation

Secondary Outcome Measures

Outcome Measure
Time Frame
first time to treatment window
Time Frame: from five days after the operation to thirty days after the operation
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
from five days after the operation to thirty days after the operation
the monitoring frequency of INR
Time Frame: 30 days after the operation
30 days after the operation
the whole-cause mortality
Time Frame: 30 days after the operation
30 days after the operation
major bleeding event
Time Frame: 30 days after the operation
30 days after the operation
major thrombosis rate
Time Frame: 30 days after the operation
30 days after the operation
absolute difference between the stable dose and initial dose
Time Frame: 30 days after the operation
30 days after the operation
the frequency of dosage change
Time Frame: 30 days after the operation
30 days after the operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xi Zhang

Collaborators

Sun Yat-sen University

Investigators

  • Study Director: Xi Zhang, MD., First Affiliated Hospital, Sun Yat-Sen University
  • Principal Investigator: Zhe Xu, MD.,PHD., First Affiliated Hospital, Sun Yat-Sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Anticipated)

August 1, 2016

Study Completion (Anticipated)

August 1, 2016

Study Registration Dates

First Submitted

June 20, 2012

First Submitted That Met QC Criteria

July 5, 2012

First Posted (Estimate)

July 6, 2012

Study Record Updates

Last Update Posted (Estimate)

July 25, 2016

Last Update Submitted That Met QC Criteria

July 22, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYSU-XZ001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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