Contact information
Type
Scientific
Primary contact
Prof Xiang-Min Xu
ORCID ID
Contact details
Technology Centre of Prenatal Diagnosis and Genetic Testing
Nanfang Hospital
Tonghe
Guangzhou
Guangdong
510515
China
+86 20 61648293
gzxuxm@pub.guangzhou.gd.cn
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
The large inter-individual variation in the requirement for warfarin is mainly result from patients genetic background, especially polymorphisms in CYP2C9 and VKORC1 genes. Here we are going to use a computational algorithm, which is validated through retrospective data, to predict the stable dose to a given patient. Our algorithm is comprised of not only physical data of the patient, but also their genetic polymorphisms.
Ethics approval
Approval received from the Nan Fang Hospital Medical Ethics Committee on the 25th April 2007 (ref: 200706)
Study design
Randomised controlled trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Not applicable
Intervention
1. Retrospective study
We enrolled 200 patients undergoing stable warfarin anticoagulation therapy. An algorithm has been established based on patients personal data including gender, age, height, weight and genotypes of CYP2C9 and VKORC1.
2. Prospective study
Treatment group: Patients stable dose will be calculated using the algorithm before they use warfarin. The first three warfarin doses will be taken according to the calculated dose. Then the doses will be adjusted depending on INR values until target INR (2.0-3.0) is obtained.
Control group: Patients use the current method to find warfarin stable dose.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Difference in stable warfarin doses among patients with genotypes CYP2C9 and VKORC1
2. An algorithm of stable warfarin dose established using multiple linear-regression equation
3. To assess the feasibility of the algorithm for treatment group compared to control group on:
3.1. Days until a stable therapeutic INR (2.0-3.0)
3.2. Days until an adverse outcome
Secondary outcome measures
1. INR, measured every day during hospitalization and twice a week after discharge
2. Warfarin dose, recorded every day
3. Adverse outcome, recorded every day
Overall trial start date
01/06/2006
Overall trial end date
31/12/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients who will initiate warfarin administration
2. Aged 18 years or more
3. Written informed consent to participate in the study
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Total of 400 subjects, 200 for retrospective study and 200 for prospective study.
Participant exclusion criteria
1. Patients with previous and current liver disease
2. Renal failure (creatinine greater than 106 μmo/L)
3. Base coagulant response time (INR) is 1.4 or more
4. Patients using any other known drugs that related to CYP2C9
5. Use of warfarin in the past three months
Recruitment start date
01/06/2006
Recruitment end date
31/12/2007
Locations
Countries of recruitment
China
Trial participating centre
Technology Centre of Prenatal Diagnosis and Genetic Testing
Guangdong
510515
China
Sponsor information
Organisation
National Natural Science Foundation of China
Sponsor details
Shuangqing Road 83
Haiding District
Beijing
100039
China
+86 010 62317474
webmaster@nsfc.gov.cn
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
National Natural Science Foundation of China (National Science Fund for Distinguished Young Scholars; ref: 30325037)
Alternative name(s)
National Science Foundation of China, Natural Science Foundation of China, NSFC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
China
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary