Condition category
Not Applicable
Date applied
06/06/2007
Date assigned
26/07/2007
Last edited
15/11/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.nsfc.gov.cn/Portal0/default99.htm

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

Publication citations

Additional files

Editorial Notes