The Study of Warfarin Maintenance Dose in Chinese Patients

• Conditions: Pulmonary Artery Embolism; Heart Valve Disease; Atrial Fibrillation
• Interventions: Drug: Warfarin

• Registration Number: NCT01855737
• Lead Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

Brief 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.

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 Timeline

• Study First Submitted: 2013-05-06
• Study First Submitted QC: 2013-05-13
• Study First Posted: 2013-05-16
• Status Verified: 2013-06
• Study Start: 2013-06
• Last Update Submitted: 2013-06-02
• Last Update Posted: 2013-06-04
• Primary Completion: 2013-12
• Study Completion: 2014-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Warfarin Using Group	Warfarin	-

Primary Outcome Measures

Name	Time	Method
The accuracy of the pharmacogenomics algorithm for warfarin maintenance dose	one month after the initial dose of warfarin	The proportion of the patients whose predicted dose were within 20% of the actual maintenance dose.

Trial Locations

Locations (1)

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