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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 Chinese Academy of Medical Sciences, Fuwai Hospital.
Recruitment status was:  Recruiting
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
  Purpose
  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.

Condition Intervention Phase
Atrial Fibrillation
Heart Valve Disease
Pulmonary Artery Embolism
Drug: Warfarin
Phase 4

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Clinical Study of the Relationship Between Pharmacogenomics and Warfarin Dose in Chinese Patients

Resource links provided by NLM:


Further study details as provided by Chinese Academy of Medical Sciences, Fuwai Hospital:

Primary Outcome Measures:
  • 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.


Biospecimen Retention:   Samples With DNA
Samples with DNA frozen in -80℃

Estimated Enrollment: 1000
Study Start Date: June 2013
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Warfarin Using Group Drug: Warfarin
Prescribe warfarin to the patients who are needed.
Other Names:
  • Manufacturer: Orion Corporation
  • Product Name: Warfarin
  • 3mg*100

Detailed Description:
  • 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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Chinese Han population who need to use Warfarin and older than 18 years old.
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01855737

Locations
China
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
Beijing, China, 100037
Sponsors and Collaborators
Chinese Academy of Medical Sciences, Fuwai Hospital
Investigators
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
  More Information

Responsible Party: Hong Liu, Key Laboratory of Clinical Trial Research in Cardiovascular Drugs, Ministry of Health, Cardiovascular Institute & Fuwai Hospital
ClinicalTrials.gov Identifier: NCT01855737     History of Changes
Other Study ID Numbers: 2011-GZH1 
Study First Received: May 6, 2013
Last Updated: June 2, 2013
Health Authority: China: Ethics Committee

Keywords provided by Chinese Academy of Medical Sciences, Fuwai Hospital:
gene guided
warfarin dose
Chinese

Additional relevant MeSH terms:
Atrial Fibrillation
Embolism
Heart Valve Diseases
Pulmonary Embolism
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Lung Diseases
Respiratory Tract Diseases
Warfarin
Anticoagulants

ClinicalTrials.gov processed this record on December 07, 2016