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The Study of Warfarin Maintenance Dose in Chinese Patients (WADCH)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Cardiovascular Institute & Fuwai Hospital
Sponsor:
Information provided by (Responsible Party):
Hong Liu, Cardiovascular Institute & Fuwai Hospital
ClinicalTrials.gov Identifier:
NCT01855737
First received: May 6, 2013
Last updated: June 2, 2013
Last verified: June 2013

May 6, 2013
June 2, 2013
June 2013
December 2013   (final data collection date for primary outcome measure)
The accuracy of the pharmacogenomics algorithm for warfarin maintenance dose [ Time Frame: one month after the initial dose of warfarin ] [ Designated as safety issue: No ]
The proportion of the patients whose predicted dose were within 20% of the actual maintenance dose.
Same as current
Complete list of historical versions of study NCT01855737 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Study of Warfarin Maintenance Dose in Chinese Patients
Clinical Study of the Relationship Between Pharmacogenomics and Warfarin Dose in Chinese Patients
  1. Title: Clinical study of the relationship between Pharmacogenomics and warfarin dose in Chinese patients
  2. Drug: Warfarin
  3. Design: To value the accuracy of warfarin Pharmacogenomics algorithm by the algorithm calculated dose and actual dose in the Chinese patients.
  4. Hypothesis:Pharmacogenomic algorithm guided dose can help to predict warfarin dose in Chinese patients.
  • For the patients who need to use warfarin, detect the "Vitamin K epoxide reductase complex subunit 1 (VKORC1),cytochrome p450 2C9 (CYP2C9), and cytochrome p450 4F2 (CYP4F2) genotype.
  • Record the demographic information: gender, age, height, and weight.
  • Record drug combination, complications, and international normalized ratio (INR), liver function and kidney function or other biochemical test results.
  • Put genotypes, demographic information and other clinical information into the algorithm to calculate warfarin dose for the patients, and compared with the actual dose.
Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Samples with DNA frozen in -80℃

Non-Probability Sample

Chinese Han population who need to use Warfarin and older than 18 years old.

  • Atrial Fibrillation
  • Heart Valve Disease
  • Pulmonary Artery Embolism
Drug: Warfarin
Prescribe warfarin to the patients who are needed.
Other Names:
  • Manufacturer: Orion Corporation
  • Product Name: Warfarin
  • 3mg*100
Warfarin Using Group
Intervention: Drug: Warfarin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
January 2014
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Chinese patients
  • Age >18y
  • target INR 1.5~3.0
  • Patients signed informed consent

Exclusion Criteria:

  • Has hemorrhage disease, or tendency to significant bleeding
  • Severe liver and kidney disfunction, serious infections, severe heart failure (NYHA heart function classification Ⅲ magnitude), severe pulmonary hypertension, abnormal thyroid function, respiratory failure, anemia, malignant tumor, blood disease
  • patients with pregnancy or lactation;
  • with cognitive impairment.
Both
18 Years and older
No
Contact: Hong Liu, MS +86 10 88398547 winterliucn@gmail.com
Contact: Yan Li, MD +86 10 88396298 sophialiyan1987@gmail.com
China
 
NCT01855737
2011-GZH1
Yes
Hong Liu, Cardiovascular Institute & Fuwai Hospital
Cardiovascular Institute & Fuwai Hospital
Not Provided
Principal Investigator: Yishi Li, MD, PhD Key Laboratory of Clinical Trial Research in Cardiovascular Drugs, Ministry of Health, Cardiovascular Institute and Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Principal Investigator: Hong Liu, MS Key Laboratory of Clinical Trial Research in Cardiovascular Drugs, Ministry of Health, Cardiovascular Institute and Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Cardiovascular Institute & Fuwai Hospital
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP