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

NCT ID: NCT02710747

Last Updated: 2016-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-07-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Genetic Group

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

Group Type EXPERIMENTAL

CYP2C9;VKORC1

Intervention Type GENETIC

Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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CYP2C9;VKORC1

Intervention Type GENETIC

Eligibility Criteria

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Inclusion Criteria

* atrial fibrillation
* heart valve replacement
* VTE

Exclusion Criteria

* severe liver or kidney diseases
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangdong Provincial People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Guangdong General Hospital

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Chen Yongbin, master

Role: CONTACT

+8618688859129

Facility Contacts

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Chen Yongbin, Master

Role: primary

+8618688859129

Other Identifiers

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GDREC2014265H

Identifier Type: -

Identifier Source: org_study_id

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