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The Pharmacogenetics of Optimal Warfarin Therapy in Chinese Patients After Heart Valve Replacement. (POWAT)

Primary Purpose

Heart Valve Disease, Older Than 18-years-old, Without Any Liver or Kidney Diseases

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
CYP2C9;VKORC1
Sponsored by
Guangdong Provincial People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Valve Disease focused on measuring warfarin, Chinese patients, heart valve replacement

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:atrial fibrillation

  • atrial fibrillation
  • heart valve replacement
  • VTE

Exclusion Criteria:

  • severe liver or kidney diseases

Sites / Locations

  • Guangdong General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Genetic Group

Control Group

Arm Description

Dose (mg/week) = [5.6044 - 0.02614 × Age [in years] + 0.0087 × Height [cm] + 0.0128 × Weight [kg] - 0.8677 × VKORC1 A/G -1.6974 × VKORC1 A/A - 0.5211 × CYP2C9 *1/*2 - 0.9357 × CYP2C9 *1/*3 - 1.0616 × CYP2C9 *2/*2 - 1.9206 × CYP2C9*2/*3 - 2.3312 × CYP2C9 *3/*3 - 0.1092 × Asian race - 0.5503 × amiodarone ]2

Dose for the first three days after operation will be 4.5mg/d.

Outcomes

Primary Outcome Measures

The perccentage of time that the INR was in the therapeutic range

Secondary Outcome Measures

all drainage fluid of every patient

Full Information

First Posted
February 25, 2016
Last Updated
March 11, 2016
Sponsor
Guangdong Provincial People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02710747
Brief Title
The Pharmacogenetics of Optimal Warfarin Therapy in Chinese Patients After Heart Valve Replacement.
Acronym
POWAT
Official Title
The Pharmacogenetics of Optimal Warfarin Therapy in Chinese Patients After Heart Valve Replacement.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
July 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guangdong Provincial People's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To value the accuracy of the dosing algorithm published by the International Warfarin Pharmacogenetics Consortium in Chinese patients after heart valve replacement. To value the accuracy of warfarin pharmacogenomics algorithm by the algorithm calculated dose and actual dose in the Chinese patients.
Detailed Description
The dosing algorithm published by the International Warfarin Pharmacogenetics Consortium hadn't been verifying by a standard randomized prospective study in Chinese patients after heart valve replacement. And, warfarin will affect people's coagulation, so that probably increase the drainage. We'll analyse the interaction of patients' PT-INR or drainge and oral warfarin dosing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Valve Disease, Older Than 18-years-old, Without Any Liver or Kidney Diseases
Keywords
warfarin, Chinese patients, heart valve replacement

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Genetic Group
Arm Type
Experimental
Arm Description
Dose (mg/week) = [5.6044 - 0.02614 × Age [in years] + 0.0087 × Height [cm] + 0.0128 × Weight [kg] - 0.8677 × VKORC1 A/G -1.6974 × VKORC1 A/A - 0.5211 × CYP2C9 *1/*2 - 0.9357 × CYP2C9 *1/*3 - 1.0616 × CYP2C9 *2/*2 - 1.9206 × CYP2C9*2/*3 - 2.3312 × CYP2C9 *3/*3 - 0.1092 × Asian race - 0.5503 × amiodarone ]2
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Dose for the first three days after operation will be 4.5mg/d.
Intervention Type
Genetic
Intervention Name(s)
CYP2C9;VKORC1
Primary Outcome Measure Information:
Title
The perccentage of time that the INR was in the therapeutic range
Time Frame
3 months
Secondary Outcome Measure Information:
Title
all drainage fluid of every patient
Time Frame
1 week after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:atrial fibrillation atrial fibrillation heart valve replacement VTE Exclusion Criteria: severe liver or kidney diseases
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chen Yongbin, master
Phone
+8618688859129
Email
chenyb1020@hotmail.com
Facility Information:
Facility Name
Guangdong General Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chen Yongbin, Master
Phone
+8618688859129
Email
chenyb1020@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

The Pharmacogenetics of Optimal Warfarin Therapy in Chinese Patients After Heart Valve Replacement.

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