Effect of CYP2C9 and VKORC1 genotype on inter-individual warfarin dose - A prospective study in Chinese population
| ISRCTN | ISRCTN54178709 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54178709 |
| Secondary identifying numbers | N/A |
- Submission date
- 06/06/2007
- Registration date
- 26/07/2007
- Last edited
- 10/06/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Xiang-Min Xu
Scientific
Scientific
Technology Centre of Prenatal Diagnosis and Genetic Testing
Nanfang Hospital
Tonghe
Guangzhou
Guangdong
510515
China
| Phone | +86 20 61648293 |
|---|---|
| gzxuxm@pub.guangzhou.gd.cn |
Study information
| Study design | Randomised controlled trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | Effect of CYP2C9 and VKORC1 genotype on inter-individual warfarin dose - A prospective study in Chinese population |
| Study objectives | 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(s) | Approval received from the Nan Fang Hospital Medical Ethics Committee on the 25th April 2007 (ref: 200706) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/06/2006 |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Total of 400 subjects, 200 for retrospective study and 200 for prospective study. |
| Total final enrolment | 422 |
| Key inclusion criteria | 1. Patients who will initiate warfarin administration 2. Aged 18 years or more 3. Written informed consent to participate in the study |
| Key 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 |
| Date of first enrolment | 01/06/2006 |
| Date of final enrolment | 31/12/2007 |
Locations
Countries of recruitment
- China
Study participating centre
Technology Centre of Prenatal Diagnosis and Genetic Testing
Guangdong
510515
China
510515
China
Sponsor information
National Natural Science Foundation of China
Government
Government
Shuangqing Road 83
Haiding District
Beijing
100039
China
| Phone | +86 010 62317474 |
|---|---|
| webmaster@nsfc.gov.cn | |
| Website | http://www.nsfc.gov.cn/Portal0/default99.htm |
"ROR" |
https://ror.org/01h0zpd94 |
Funders
Funder type
Government
National Natural Science Foundation of China (National Science Fund for Distinguished Young Scholars; ref: 30325037)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Chinese National Science Foundation, Natural Science Foundation of China, National Science Foundation of China, NNSF of China, NSF of China, 国家自然科学基金委员会, National Nature Science Foundation of China, Guójiā Zìrán Kēxué Jījīn Wěiyuánhuì, NSFC, NNSF, NNSFC
- Location
- China
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/03/2009 | 10/06/2021 | Yes | No |
Editorial Notes
10/06/2021: Publication reference and total final enrolment added.
