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

Guangdong Provincial People's Hospital (Guangdong Provincial Academy of Medical Sciences)

Status and phase: Unknown; Phase 4

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

Treatments: Genetic: CYP2C9;VKORC1

Study type: Interventional

Funder types: Other

Identifiers

NCT02710747

GDREC2014265H

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:atrial fibrillation

• atrial fibrillation
• heart valve replacement
• VTE

Exclusion Criteria:

• severe liver or kidney diseases

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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500 participants in 2 patient groups

Genetic Group

Experimental group

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

Treatment:

Genetic: CYP2C9;VKORC1

Control Group

No Intervention group

Description:

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