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Trial record 39 of 1109 for:    pharmacogenomics OR pharmacogenetics

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

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ClinicalTrials.gov Identifier: NCT02710747
Recruitment Status : Unknown
Verified December 2015 by Guangdong Provincial People's Hospital.
Recruitment status was:  Recruiting
First Posted : March 17, 2016
Last Update Posted : March 17, 2016
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Heart Valve Disease Older Than 18-years-old Without Any Liver or Kidney Diseases Genetic: CYP2C9;VKORC1 Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: The Pharmacogenetics of Optimal Warfarin Therapy in Chinese Patients After Heart Valve Replacement.
Study Start Date : January 2015
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arm Intervention/treatment
Experimental: 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
Genetic: CYP2C9;VKORC1
No Intervention: Control Group
Dose for the first three days after operation will be 4.5mg/d.



Primary Outcome Measures :
  1. The perccentage of time that the INR was in the therapeutic range [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. all drainage fluid of every patient [ Time Frame: 1 week after operation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:atrial fibrillation

  • atrial fibrillation
  • heart valve replacement
  • VTE

Exclusion Criteria:

  • severe liver or kidney diseases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02710747


Contacts
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Contact: Chen Yongbin, master +8618688859129 chenyb1020@hotmail.com

Locations
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China, Guangdong
Guangdong General Hospital Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Chen Yongbin, Master    +8618688859129    chenyb1020@hotmail.com   
Sponsors and Collaborators
Guangdong Provincial People's Hospital

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Responsible Party: Guangdong Provincial People's Hospital
ClinicalTrials.gov Identifier: NCT02710747     History of Changes
Other Study ID Numbers: GDREC2014265H
First Posted: March 17, 2016    Key Record Dates
Last Update Posted: March 17, 2016
Last Verified: December 2015
Keywords provided by Guangdong Provincial People's Hospital:
warfarin
Chinese patients
heart valve replacement
Additional relevant MeSH terms:
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Kidney Diseases
Heart Valve Diseases
Urologic Diseases
Heart Diseases
Cardiovascular Diseases
Warfarin
Anticoagulants