Clinical trial NCT01855737: The Study of Warfarin Maintenance Dose in Chinese Patients
Official title: Clinical Study of the Relationship Between Pharmacogenomics and Warfarin Dose in Chinese Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Heart Valve Disease
Pulmonary Artery Embolism
Keywords: gene guided
warfarin dose
Chinese
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2013-05-16
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chinese Han population who need to use Warfarin and older than 18 years old.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The accuracy of the pharmacogenomics algorithm for warfarin maintenance dose
timeFrame: one month after the initial dose of warfarin
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: 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
Study officials:
affiliation: 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
name: Yishi Li, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: 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
name: Hong Liu, MS
role: PRINCIPAL_INVESTIGATOR
References: