Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
300 participants
INTERVENTIONAL
2009-09-30
2013-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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).
Standard of care dosing for warfarin
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).
Genotype-guided dosingTaiwan algorithm for warfarin
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).
Genotype-guided dosing IWPC algorithm for warfarin
Interventions
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Standard of care dosing for warfarin
Genotype-guided dosingTaiwan algorithm for warfarin
Genotype-guided dosing IWPC algorithm for warfarin
Eligibility Criteria
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Inclusion Criteria
* 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 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
20 Years
ALL
No
Sponsors
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Chang Gung Memorial Hospital
OTHER
China Medical University Hospital
OTHER
Kaohsiung Medical University
OTHER
Academia Sinica, Taiwan
OTHER
Responsible Party
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Principal Investigators
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Ming Ta Michael Lee, PhD
Role: PRINCIPAL_INVESTIGATOR
Institute of Biomedical Sciences, Academia Sinica
Locations
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Kaohsiung Medical University
Kaohsiung City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
Chang Gung Memorial Hospital
Taoyuan District, , Taiwan
Countries
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References
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Ohara M, Takahashi H, Lee MT, Wen MS, Lee TH, Chuang HP, Luo CH, Arima A, Onozuka A, Nagai R, Shiomi M, Mihara K, Morita T, Chen YT. Determinants of the over-anticoagulation response during warfarin initiation therapy in Asian patients based on population pharmacokinetic-pharmacodynamic analyses. PLoS One. 2014 Aug 22;9(8):e105891. doi: 10.1371/journal.pone.0105891. eCollection 2014.
Other Identifiers
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AS-IRB01-100070
Identifier Type: -
Identifier Source: org_study_id
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