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ISRCTN
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ISRCTN54178709
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ClinicalTrials.gov identifier
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Public title
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Effect of CYP2C9 and VKORC1 genotype on inter-individual warfarin dose - A prospective study in Chinese population
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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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.
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Ethics approval
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Approval received from the Nan Fang Hospital Medical Ethics Committee on the 25th April 2007 (ref: 200706)
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Study design
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Randomised controlled trial.
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Countries of recruitment
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China
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Disease/condition/study domain
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Not applicable
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Participants - inclusion criteria
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1. Patients who will initiate warfarin administration
2. Aged 18 years or more
3. Written informed consent to participate in the study
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Participants - exclusion criteria
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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
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Anticipated start date
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01/06/2006
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Anticipated end date
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31/12/2007
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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Total of 400 subjects, 200 for retrospective study and 200 for prospective study.
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Interventions
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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.
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Primary outcome measure(s)
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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
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Secondary outcome measure(s)
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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
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Sources of funding
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National Natural Science Foundation of China (National Science Fund for Distinguished Young Scholars; ref: 30325037)
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Trial website
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Publications
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Contact name
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Prof
Xiang-Min
Xu
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Address
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Technology Centre of Prenatal Diagnosis and Genetic Testing
Nanfang Hospital
Tonghe
Guangzhou
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City/town
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Guangdong
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Zip/Postcode
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510515
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Country
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China
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Tel
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+86 20 61648293
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Fax
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+86 20 87278766
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Email
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gzxuxm@pub.guangzhou.gd.cn
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Sponsor
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National Natural Science Foundation of China
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Address
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Shuangqing Road 83
Haiding District
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City/town
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Beijing
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Zip/Postcode
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100039
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Country
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China
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Tel
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+86 010 62317474
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Fax
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+86 010 62326873
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Email
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webmaster@nsfc.gov.cn
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Sponsor website:
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http://www.nsfc.gov.cn/Portal0/default99.htm
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Date applied
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06/06/2007
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Last edited
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15/11/2007
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Date ISRCTN assigned
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26/07/2007
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