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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2013 by Hong Liu, Cardiovascular Institute & Fuwai Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01855737
First Posted: May 16, 2013
Last Update Posted: June 4, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hong Liu, Cardiovascular Institute & Fuwai Hospital
May 6, 2013
May 16, 2013
June 4, 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 ]
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
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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.
 
Unknown status
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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01855737
2011-GZH1
Yes
Not Provided
Not Provided
Hong Liu, Cardiovascular Institute & Fuwai Hospital
Chinese Academy of Medical Sciences, 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
Chinese Academy of Medical Sciences, Fuwai Hospital
June 2013
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