The Study of Warfarin Maintenance Dose in Chinese Patients (WADCH)
|ClinicalTrials.gov Identifier: NCT01855737|
Recruitment Status : Unknown
Verified June 2013 by Hong Liu, Cardiovascular Institute & Fuwai Hospital.
Recruitment status was: Recruiting
First Posted : May 16, 2013
Last Update Posted : June 4, 2013
- Title: Clinical study of the relationship between Pharmacogenomics and warfarin dose in Chinese patients
- Drug: Warfarin
- Design: To value the accuracy of warfarin Pharmacogenomics algorithm by the algorithm calculated dose and actual dose in the Chinese patients.
- Hypothesis:Pharmacogenomic algorithm guided dose can help to predict warfarin dose in Chinese patients.
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation Heart Valve Disease Pulmonary Artery Embolism||Drug: Warfarin||Phase 4|
- 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 Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||Clinical Study of the Relationship Between Pharmacogenomics and Warfarin Dose in Chinese Patients|
|Study Start Date :||June 2013|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||January 2014|
|Warfarin Using Group||
Prescribe warfarin to the patients who are needed.
- The accuracy of the pharmacogenomics algorithm for warfarin maintenance dose [ Time Frame: one month after the initial dose of warfarin ]The proportion of the patients whose predicted dose were within 20% of the actual maintenance dose.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01855737
|Contact: Hong Liu, MS||+86 10 email@example.com|
|Contact: Yan Li, MD||+86 10 firstname.lastname@example.org|
|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||Recruiting|
|Beijing, China, 100037|
|Contact: Yishi Li, MD, PhD +86 10 88398395 email@example.com|
|Contact: Yiling Huang, MS +86 10 88398395 firstname.lastname@example.org|
|Sub-Investigator: Yan Li, MD|
|Sub-Investigator: Ying Lou, MD|
|Principal Investigator:||Yishi Li, MD, PhD||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|
|Principal Investigator:||Hong Liu, MS||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|