Applying Pharmacogenetics to Warfarin Dosing in Chinese Patients
1 other identifier
interventional
500
1 country
1
Brief Summary
The purpose of this study is to determine whether pharmacogenetic guided dosing of warfarin is promising for the improvement of efficiency, therapeutic efficacy, and, especially, safety of warfarin therapy than a dosing regimen without the pharmacogenetic information in Chinese patients initiated on warfarin anticoagulation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 atrial-fibrillation
Started Jun 2012
Typical duration for phase_4 atrial-fibrillation
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 30, 2012
CompletedFirst Posted
Study publicly available on registry
June 1, 2012
CompletedStudy Start
First participant enrolled
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedOctober 9, 2013
October 1, 2013
2 years
May 30, 2012
October 7, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
A comparison between the pharmacogenetic and standard arms of the per-patient percentage of out-of-range INRs (<1.5, >3).
3 months
Secondary Outcomes (8)
Time to the first supratherapeutic INR
3 months
The proportion of time within the therapeutic INR range
3 months
The proportion of patients reaching therapeutic INR on days 5 and 8
3 months
The total number of INR measurements and number of dose adjustments made
3 months
Proportion of INRs > 4
3 months
- +3 more secondary outcomes
Study Arms (2)
Genotype-guided warfarin dosing
EXPERIMENTALA pharmacogenetic dosing algorithm including clinical factors and genotype information (VKORC1, CYP2C9 and CYP4F2) will be used to determine warfarin doses.
Non-genotype guided warfarin dosing
ACTIVE COMPARATORA fixed warfarin dose of 3 mg/day was given to the patients for at least 3 days. Following doses were adjusted according to the INR measurement.
Interventions
Applying a Pharmacogenetic-guided warfarin dosing algorithm derived from Chinese to determine the daily maintenance dose of warfarin, based on clinical factors (age, sex, body surface area, etc.), and VKORC1, CYP2C9 and CYP4F2 genotypes, to individualize the dosing of warfarin.
A Empiric fixed warfarin dose of 3 mg/day was given to the patients for at least 3 days. Following doses were adjusted according to the INR measurement.
Eligibility Criteria
You may qualify if:
- Patients ≥18 years old
- Patients initiated on warfarin for venous thromboembolism, pulmonary embolism, atrial fibrillation or heart valve replacement that require long- term oral anticoagulation with target INR ranged 1.5-3.0 for at least 3 months
- Ability to attend scheduled visits
- Signed informed consent
You may not qualify if:
- Non-eligible subject
- Pregnant,lactating or of child-bearing potential women
- Patients with severe co-morbidities (e.g., renal insufficiency/creatinine \> 2.5 mg/dL,hepatic insufficiency, active malignancy, terminal disease)
- Known genotype CYP2C9 or VKORC1 at start of the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of geriatric Cardiology, General Hospital of People's Liberation Army
Beijing, 100853, China
Related Publications (1)
Liu Y, Yang J, Xu Q, Xu B, Gao L, Zhang Y, Zhang Y, Wang H, Lu C, Zhao Y, Yin T. Comparative performance of warfarin pharmacogenetic algorithms in Chinese patients. Thromb Res. 2012 Sep;130(3):435-40. doi: 10.1016/j.thromres.2012.02.003. Epub 2012 Feb 27.
PMID: 22374335BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tong Yin, Dr.
Institute of Geriatric Cardiology, General Hospital of People's Liberation Army, Beijing China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Institute of Geriatric Cardiology
Study Record Dates
First Submitted
May 30, 2012
First Posted
June 1, 2012
Study Start
June 1, 2012
Primary Completion
June 1, 2014
Study Completion
June 1, 2015
Last Updated
October 9, 2013
Record last verified: 2013-10