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 General Hospital.
Recruitment status was: Recruiting
First Posted : March 17, 2016
Last Update Posted : March 17, 2016
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|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|
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
No Intervention: Control Group
Dose for the first three days after operation will be 4.5mg/d.
- The perccentage of time that the INR was in the therapeutic range [ Time Frame: 3 months ]
- all drainage fluid of every patient [ Time Frame: 1 week after operation ]
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
|Contact: Chen Yongbin, firstname.lastname@example.org|
|Guangdong General Hospital||Recruiting|
|Guangzhou, Guangdong, China, 510080|
|Contact: Chen Yongbin, Master +8618688859129 email@example.com|