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NCT02710747 Clinical Trial

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

Heart Valve Disease Clinical Trial

— POWAT  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02710747
Other study ID # GDREC2014265H
Secondary ID
Status Recruiting
Phase Phase 4
First received February 25, 2016
Last updated March 11, 2016
Start date January 2015
Est. completion date July 2016

Study information
Verified date December 2015
Source Guangdong General Hospital
Contact Chen Yongbin, master
Phone +8618688859129
Email chenyb1020@hotmail.com
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date July 2016
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:atrial fibrillation

- atrial fibrillation

- heart valve replacement

- VTE

Exclusion Criteria:

- severe liver or kidney diseases

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Genetic:
• CYP2C9;VKORC1

Locations
Country Name City State
China Guangdong General Hospital Guangzhou Guangdong

Sponsors (1)
Lead Sponsor Collaborator
Guangdong General Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary The perccentage of time that the INR was in the therapeutic range 3 months Yes
Secondary all drainage fluid of every patient 1 week after operation Yes
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