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

June 2, 2013 updated by: Hong Liu, Chinese Academy of Medical Sciences, Fuwai Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100037
        • Recruiting
        • 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
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Yan Li, MD
        • Sub-Investigator:
          • Ying Lou, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Warfarin Using Group
Drug: Warfarin
Prescribe warfarin to the patients who are needed.
Other Names:
  • Manufacturer: Orion Corporation
  • Product Name: Warfarin
  • 3mg*100

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
one month after the initial dose of warfarin

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (ANTICIPATED)

December 1, 2013

Study Completion (ANTICIPATED)

January 1, 2014

Study Registration Dates

First Submitted

May 6, 2013

First Submitted That Met QC Criteria

May 13, 2013

First Posted (ESTIMATE)

May 16, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

June 4, 2013

Last Update Submitted That Met QC Criteria

June 2, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-GZH1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Atrial Fibrillation

Clinical Trials on Warfarin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Dominican Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe