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

Chinese Academy of Medical Sciences, Fuwai Hospital

Status: Unknown

Conditions: Atrial Fibrillation; Pulmonary Artery Embolism; Heart Valve Disease

Treatments: Drug: Warfarin

Study type: Observational

Funder types: Other

Identifiers

NCT01855737

2011-GZH1

Details and patient eligibility

About

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 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

1,000 participants in 1 patient group

Warfarin Using Group

Treatment:

Drug: Warfarin