The Study of Warfarin Maintenance Dose in Chinese Patients

Atrial Fibrillation Clinical Trial

— WADCH  

Official title:

Clinical Study of the Relationship Between Pharmacogenomics and Warfarin Dose in Chinese Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01855737
• Other study ID #: 2011-GZH1
• Status: Recruiting
• Phase: Phase 4
• First received: May 6, 2013
• Last updated: June 2, 2013
• Start date: June 2013
• Est. completion date: January 2014

Study information

• Verified date: June 2013
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: Hong Liu, MS
• Phone: +86 10 88398547
• Email: winterliucn[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: January 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 ? magnitude), severe pulmonary hypertension, abnormal thyroid function, respiratory failure, anemia, malignant tumor, blood disease

• patients with pregnancy or lactation;

• with cognitive impairment.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Atrial Fibrillation
• Heart Valve Disease
• Heart Valve Diseases
• Pulmonary Artery Embolism
• Pulmonary Embolism

Intervention

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

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The accuracy of the pharmacogenomics algorithm for warfarin maintenance dose	The proportion of the patients whose predicted dose were within 20% of the actual maintenance dose.	one month after the initial dose of warfarin	No