- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02065388
Pharmacogenetic Dosing of Warfarin
Purpose:
Warfarin is now the most commonly used oral anticoagulant. This drug has inter-individual variability due to the genetic polymorphisms in the warfarin metabolizing enzyme, CYP2C9 and warfarin target, VKORC1. The investigators' team developed a pharmacogenetic dosing algorithm which can predict patients required warfarin dose, thus could prevent warfarin induced warfarin adverse events.
Methods:
The investigators recruited patients with indications for warfarin, the genotypes of VKORC1 and CYP2C9 were determined by the hospitals and verified by National Center for Genome Medicine. The investigators then randomized the patients to one of three arms: 1. Warfarin dose predicted by dosing algorithm developed by the International Warfarin pharmacogenetic Consortium (IWPC), 2. Algorithm developed by the Taiwan Warfarin Consortium and 3. Standard of care. The investigators aimed to determine whether using genetic dosing algorithm can lead to more stable dose and safer use of the drug.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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-
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Kaohsiung, Taiwan, 807
- Kaohsiung Medical University
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Taichung, Taiwan, 404
- China Medical University Hospital
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Taoyuan, Taiwan, 333
- Chang Gung Memorial Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients must give their informed consent and complete the case report form.
- Patients must be over the age of 20.
- Patients have clinical indications for warfarin therapy but do not have any prior warfarin treatment.
Exclusion Criteria:
- Patients who did not complete the informed consent form or the CRF
- Patients who are less than the age of 20.
- Patients who had prior or is currently on warfarin treatment.
- Patients who have hemorrhagic tendencies or hemorrhagic diseases defined as copious bleeding caused by viral or bacterial infections; cancer and hepatic dysfunction defined as GOP and GPT values three times higher than normal value
- Patients who has Vitamin K deficiency
- Female patients who is currently pregnant
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Standard of care dosing for warfarin
Loading dose (5mg) of warfarin for the first 3 days of treatment.
Dose adjustment after initiation will using guideline modified from Tait el al. (1998).
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|
Experimental: Genotype-guided dosingTaiwan algorithm for warfarin
Initial loading dosing of warfarin for the first 3 days of treatment will be determined by the Taiwan algorithm that uses clinical and genetic information.
Dose adjustment after initiation will using guideline modified from Tait el al. (1998).
|
|
Experimental: Genotype-guided dosing IWPC algorithm for warfarin
Initial loading dosing of warfarin for the first 3 days of treatment will be determined by the IWPC algorithm that uses clinical and genetic information.
Dose adjustment after initiation will using guideline modified from Tait el al. (1998).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time spent in target INR range
Time Frame: first month of therapy
|
time spent in target INR range Time in the target INR Range will be the primary endpoints because of its strong association with adverse events: patients with subtherapeutic INR values are at increased risk of thrombosis and patients with high INR values are at increased risk of hemorrhage during warfarin treatment initiation.
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first month of therapy
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ming Ta Michael Lee, PhD, Institute of Biomedical Sciences, Academia Sinica
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AS-IRB01-100070
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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