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

Primary Purpose

Anticoagulation Treatment Overdose, Heart Valve Diseases

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Genotype-based Warfarin Initiation model
clinical factor-based warfarin initiation model
Sponsored by
Xi Zhang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anticoagulation Treatment Overdose focused on measuring anticoagulation, bleeding, CYP2C9, CYP4F2, VKORC1, warfarin dosing, Heart Valve Diseases, pharmacogenomics

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The first affiliated hospital of Sun Yat Sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Genotype-based Warfarin Initiation

clinical factor-based warfarin initiation

Arm Description

Outcomes

Primary Outcome Measures

time to steady dosage
Time in Therapeutic Range

Secondary Outcome Measures

first time to treatment window
the ratio of INR≥3.0 and INR≤1.5
the monitoring frequency of INR
the whole-cause mortality
major bleeding event
major thrombosis rate
absolute difference between the stable dose and initial dose
the frequency of dosage change

Full Information

First Posted
June 20, 2012
Last Updated
July 22, 2016
Sponsor
Xi Zhang
Collaborators
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT01633957
Brief Title
A Trial of Genotype-based Warfarin Initiation in Patients With Mechanical Prosthetic Heart Valve
Acronym
SYSU-WARFA
Official Title
Academic Leader，Head of Cardiac Surgery,Principal Investigator, Clinical Professor
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2012 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
August 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Xi Zhang
Collaborators
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anticoagulation Treatment Overdose, Heart Valve Diseases
Keywords
anticoagulation, bleeding, CYP2C9, CYP4F2, VKORC1, warfarin dosing, Heart Valve Diseases, pharmacogenomics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Genotype-based Warfarin Initiation
Arm Type
Experimental
Arm Title
clinical factor-based warfarin initiation
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Genotype-based Warfarin Initiation model
Intervention Description
Based on previous retrospective study,investigators established a genotype-based warfarin model to estimate the drug dosage.
Intervention Type
Other
Intervention Name(s)
clinical factor-based warfarin initiation model
Intervention Description
Based on previous retrospective study,investigators established a clinical factor-based warfarin model to estimate the drug dosage.
Primary Outcome Measure Information:
Title
time to steady dosage
Time Frame
from seven days after the operation to thirty days after the operation
Title
Time in Therapeutic Range
Time Frame
from five days after the operation to thirty days after the operation
Secondary Outcome Measure Information:
Title
first time to treatment window
Time Frame
from five days after the operation to thirty days after the operation
Title
the ratio of INR≥3.0 and INR≤1.5
Time Frame
from five days after the operation to thirty days after the operation
Title
the monitoring frequency of INR
Time Frame
30 days after the operation
Title
the whole-cause mortality
Time Frame
30 days after the operation
Title
major bleeding event
Time Frame
30 days after the operation
Title
major thrombosis rate
Time Frame
30 days after the operation
Title
absolute difference between the stable dose and initial dose
Time Frame
30 days after the operation
Title
the frequency of dosage change
Time Frame
30 days after the operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xi Zhang, MD.
Phone
86-13902279690
Email
zhangxisysu@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhe Xu, MD.,PHD.
Phone
86-13828453339
Email
xuzhesums@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xi Zhang, MD.
Organizational Affiliation
First Affiliated Hospital, Sun Yat-Sen University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Zhe Xu, MD.,PHD.
Organizational Affiliation
First Affiliated Hospital, Sun Yat-Sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The first affiliated hospital of Sun Yat Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xi Zhang, MD.
Phone
86-13902279690
Email
zhangxisysu@163.com
First Name & Middle Initial & Last Name & Degree
Zhe Xu, MD.PHD.
Phone
86-13828453339
Email
xuzhesums@163.com
First Name & Middle Initial & Last Name & Degree
Zhe Xu, MD.PHD.

12. IPD Sharing Statement

Links:
URL
http://warfarindosing.org/Source/Home.aspx
Description
one of the best warfarin dose model

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

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