Clinical Trials Logo
  1. Home
  2. Heart Valve Disease
  3. NCT02710747
  4. Details
NCT02710747 Clinical Trial

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

Heart Valve Disease Clinical Trial

— POWAT  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02710747
Other study ID # GDREC2014265H
Secondary ID
Status Recruiting
Phase Phase 4
First received February 25, 2016
Last updated March 11, 2016
Start date January 2015
Est. completion date July 2016

Study information
Verified date December 2015
Source Guangdong General Hospital
Contact Chen Yongbin, master
Phone +8618688859129
Email chenyb1020@hotmail.com
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date July 2016
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:atrial fibrillation

- atrial fibrillation

- heart valve replacement

- VTE

Exclusion Criteria:

- severe liver or kidney diseases

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Genetic:
• CYP2C9;VKORC1

Locations
Country Name City State
China Guangdong General Hospital Guangzhou Guangdong

Sponsors (1)
Lead Sponsor Collaborator
Guangdong General Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary The perccentage of time that the INR was in the therapeutic range 3 months Yes
Secondary all drainage fluid of every patient 1 week after operation Yes
See also
  Status Clinical Trial Phase
Recruiting NCT06027788 - CTSN Embolic Protection Trial N/A
Completed NCT02527629 - Aortic Replacement Using Individualised Regenerative Allografts - ARISE (the "Surveillance")
Completed NCT01178710 - Effect of Simvastatin on Cardiac Function N/A
Completed NCT01426776 - Effect of Heart Valve Replacement on Cheyne-Stokes Respiration N/A
Completed NCT00581399 - A Randomized Multicenter Clinical Study On the High Vacuum Body Cavity Drainage System Following Open Heart Surgery Phase 2
Withdrawn NCT00187304 - ACTION - Anticoagulation Treatment Influence on Post-operative Patients Phase 4
Terminated NCT00700947 - Using Beta Blockers to Treat Mitral Regurgitation Phase 1
Recruiting NCT02574650 - Early Feasibility of the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) Also Known as TriAlign™. N/A
Recruiting NCT02650388 - Frailty and Cognitive Function Assessment of TAVI Patients Phase 4
Completed NCT01996657 - D-dimer and Oral Anticoagulation Therapy in Patients With Mechanical Valve Replacement N/A
Terminated NCT00598936 - A Prospective Study With a New Device for the Monitoring of Cerebral Oxygenation on Cardiac Surgery Patients Phase 1
Terminated NCT01812174 - On-X Heart Valve - 17mm Aortic and 23mm Mitral N/A
Recruiting NCT03225612 - Safety and Performance of the Trialign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) N/A
Completed NCT01384643 - Effect of Propofol on Renal Injury in Patients Undergoing Valvular Heart Surgery Phase 4
Completed NCT01558765 - CopenHeartVR - Integrated Rehabilitation of Patients After Heart Valve Surgery Phase 2
Active, not recruiting NCT00291525 - Randomized On-X Anticoagulation Trial N/A
Completed NCT02867930 - Comparative Effects of Dexmedetomidine and Ketofol for Sedation in Patients Undergoing Trans-esophageal Echocardiography Phase 4
Recruiting NCT02478008 - A Clinical Study of the CardiAQ™ TMVI System (Transapical DS) N/A
Completed NCT02790008 - Magnetic Resonance Imaging and Fibrosis
Completed NCT02587039 - An Intervention to Reduce Delirium After Cardiac Surgery N/A