The Pharmacogenetics of Optimal Warfarin Therapy in Chine... | NCT02710747

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

NCT02710747

Sponsor

Guangdong Provincial People's Hospital

Status

Unknown status

Last Update Posted

Mar 17, 2016Estimated

Enrollment

500Estimated

Phase

Phase 4

Conditions

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

Interventions

CYP2C9;VKORC1

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015

Primary Completion Date

Jun 2016Estimated

Completion Date

Jul 2016Estimated

First Submitted Date

Feb 25, 2016

First Submission Date that Met QC Criteria

Mar 11, 2016

First Posted Date

Mar 17, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 11, 2016

Last Update Posted Date

Mar 17, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Genetic Group	Experimental	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 × CYP2C92/3 - 2.3312 × CYP2C9 3/3 - 0.1092 × Asian race - 0.5503 × amiodarone ]2	Genetic: CYP2C9;VKORC1
Control Group	No Intervention	Dose for the first three days after operation will be 4.5mg/d.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CYP2C9;VKORC1	Genetic		Genetic Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The perccentage of time that the INR was in the therapeutic range		3 months

Secondary Outcomes

Measure	Description	Time Frame
all drainage fluid of every patient		1 week after operation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:atrial fibrillation

atrial fibrillation
heart valve replacement
VTE

Exclusion Criteria:

severe liver or kidney diseases

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Chen Yongbin, master	Contact	+8618688859129		chenyb1020@hotmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Guangdong General Hospital	Recruiting	Guangzhou	Guangdong	510080	China

Condition Browse Module

MeSH Terms

ID	Term
D006349	Heart Valve Diseases
D007674	Kidney Diseases

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided