WADCH: The Study of Warfarin Maintenance Dose in Chinese Patients
Study Details
Study Description
Brief Summary
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Title: Clinical study of the relationship between Pharmacogenomics and warfarin dose in Chinese patients
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Drug: Warfarin
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Design: To value the accuracy of warfarin Pharmacogenomics algorithm by the algorithm calculated dose and actual dose in the Chinese patients.
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Hypothesis:Pharmacogenomic algorithm guided dose can help to predict warfarin dose in Chinese patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Detailed Description
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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.
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Record the demographic information: gender, age, height, and weight.
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Record drug combination, complications, and international normalized ratio (INR), liver function and kidney function or other biochemical test results.
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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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Warfarin Using Group
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Drug: Warfarin
Prescribe warfarin to the patients who are needed.
Other Names:
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Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Chinese patients
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Age >18y
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target INR 1.5~3.0
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Patients signed informed consent
Exclusion Criteria:
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Has hemorrhage disease, or tendency to significant bleeding
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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
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patients with pregnancy or lactation;
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with cognitive impairment.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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 | Beijing | China | 100037 |
Sponsors and Collaborators
- Chinese Academy of Medical Sciences, Fuwai Hospital
Investigators
- 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2011-GZH1