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

• Sponsor: Guangdong Provincial People's Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02710747
• Collaborator: (none)
• Enrollment: 500
• Location: 1
• Arms: 2
• Duration (Months): 18
• Patients Per Site Per Month: 27.8

Study Details

Study Description

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.

Study Design

• Study Type: Interventional
• Anticipated 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: Jan 1, 2015
• Anticipated Primary Completion Date: Jun 1, 2016
• Anticipated Study Completion Date: Jul 1, 2016

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. The perccentage of time that the INR was in the therapeutic range [3 months]

Secondary Outcome Measures

1. all drainage fluid of every patient [1 week after operation]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:atrial fibrillation

• atrial fibrillation

• heart valve replacement

• VTE

Exclusion Criteria:

• severe liver or kidney diseases

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Guangdong General Hospital	Guangzhou	Guangdong	China	510080

Sponsors and Collaborators

• Guangdong Provincial People's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Guangdong Provincial People's Hospital
• ClinicalTrials.gov Identifier: NCT02710747
• Other Study ID Numbers: GDREC2014265H
• First Posted: Mar 17, 2016
• Last Update Posted: Mar 17, 2016
• Last Verified: Dec 1, 2015

• Keywords provided by Guangdong Provincial People's Hospital: warfarin; Chinese patients; heart valve replacement
• Additional relevant MeSH terms: Kidney Diseases; Heart Valve Diseases

Study Results

No Results Posted as of Mar 17, 2016