The Study of Warfarin Maintenance Dose in Chinese Patients

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01855737

Acronym

WADCH

Enrollment

1000

Registered

2013-05-16

Start date

2013-06-30

Completion date

2014-01-31

Last updated

2013-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Heart Valve Disease, Pulmonary Artery Embolism

Keywords

gene guided, warfarin dose, Chinese

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.

Interventions

DRUGWarfarin

Prescribe warfarin to the patients who are needed.

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

China

Contacts

Primary ContactHong Liu, MS

winterliucn@gmail.com+86 10 88398547

Backup ContactYan Li, MD

sophialiyan1987@gmail.com+86 10 88396298

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026