The Study of Warfarin Maintenance Dose in Chinese Patients
WADCH
Clinical Study of the Relationship Between Pharmacogenomics and Warfarin Dose in Chinese Patients
1 other identifier
observational
1,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2013
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2013
CompletedFirst Posted
Study publicly available on registry
May 16, 2013
CompletedStudy Start
First participant enrolled
June 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedJune 4, 2013
June 1, 2013
6 months
May 6, 2013
June 2, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The accuracy of the pharmacogenomics algorithm for warfarin maintenance dose
The proportion of the patients whose predicted dose were within 20% of the actual maintenance dose.
one month after the initial dose of warfarin
Study Arms (1)
Warfarin Using Group
Interventions
Prescribe warfarin to the patients who are needed.
Eligibility Criteria
Chinese Han population who need to use Warfarin and older than 18 years old.
You may qualify if:
- Chinese patients
- Age \>18y
- target INR 1.5\~3.0
- Patients signed informed consent
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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, 100037, China
Biospecimen
Samples with DNA frozen in -80℃
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Key Laboratory of Clinical Trial Research in Cardiovascular Drugs, Ministry of Health
Study Record Dates
First Submitted
May 6, 2013
First Posted
May 16, 2013
Study Start
June 1, 2013
Primary Completion
December 1, 2013
Study Completion
January 1, 2014
Last Updated
June 4, 2013
Record last verified: 2013-06