The Study of Warfarin Maintenance Dose in Chinese Patients

Overview

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.

Full Title of Study: “Clinical Study of the Relationship Between Pharmacogenomics and Warfarin Dose in Chinese Patients”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2013

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.

Interventions

  • Drug: Warfarin
    • Prescribe warfarin to the patients who are needed.

Arms, Groups and Cohorts

  • Warfarin Using Group

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Chinese Academy of Medical Sciences, Fuwai Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Hong Liu, Key Laboratory of Clinical Trial Research in Cardiovascular Drugs, Ministry of Health – Chinese Academy of Medical Sciences, Fuwai Hospital
  • Overall Official(s)
    • Yishi Li, MD, PhD, Principal Investigator, 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
    • Hong Liu, MS, Principal Investigator, 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
  • Overall Contact(s)
    • Hong Liu, MS, +86 10 88398547, winterliucn@gmail.com

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