The Study of Warfarin Maintenance Dose in Chinese Patients (WADCH)
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|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|