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

Phase 4

• Conditions: Older Than 18-years-old; Without Any Liver or Kidney Diseases; Heart Valve Disease
• Interventions: Genetic: CYP2C9;VKORC1

• Registration Number: NCT02710747
• Lead Sponsor: Guangdong Provincial People's Hospital

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.

Study Timeline

• Study Start: 2015-01
• Status Verified: 2015-12
• Study First Submitted: 2016-02-25
• Study First Submitted QC: 2016-03-11
• Last Update Submitted: 2016-03-11
• Study First Posted: 2016-03-17
• Last Update Posted: 2016-03-17
• Primary Completion: 2016-06
• Study Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

atrial fibrillation

• atrial fibrillation
• heart valve replacement
• VTE

Exclusion Criteria

• severe liver or kidney diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Genetic Group	CYP2C9;VKORC1	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

Primary Outcome Measures

Name	Time	Method
The perccentage of time that the INR was in the therapeutic range	3 months

Secondary Outcome Measures

Name	Time	Method
all drainage fluid of every patient	1 week after operation

Trial Locations

Locations (1)

Guangdong General Hospital; 🇨🇳 Guangzhou, Guangdong, China