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Pharmacogenetic Dosing of Warfarin

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ClinicalTrials.gov Identifier: NCT02065388
Recruitment Status : Completed
First Posted : February 19, 2014
Last Update Posted : February 19, 2014
Sponsor:
Collaborators:
Chang Gung Memorial Hospital
China Medical University Hospital
Kaohsiung Medical University
Information provided by (Responsible Party):
Academia Sinica, Taiwan

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Stroke Venous Thrombosis Atrial Fibrillation Atrial Flutter Behavioral: Standard of care dosing for warfarin Genetic: Genotype-guided dosingTaiwan algorithm for warfarin Genetic: Genotype-guided dosing IWPC algorithm for warfarin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : September 2009
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

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).
Behavioral: Standard of care dosing for warfarin
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).
Genetic: Genotype-guided dosingTaiwan algorithm for warfarin
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).
Genetic: Genotype-guided dosing IWPC algorithm for warfarin



Primary Outcome Measures :
  1. 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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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02065388


Locations
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Taiwan
Kaohsiung Medical University
Kaohsiung, Taiwan, 807
China Medical University Hospital
Taichung, Taiwan, 404
Chang Gung Memorial Hospital
Taoyuan, Taiwan, 333
Sponsors and Collaborators
Academia Sinica, Taiwan
Chang Gung Memorial Hospital
China Medical University Hospital
Kaohsiung Medical University
Investigators
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Principal Investigator: Ming Ta Michael Lee, PhD Institute of Biomedical Sciences, Academia Sinica

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Academia Sinica, Taiwan
ClinicalTrials.gov Identifier: NCT02065388     History of Changes
Other Study ID Numbers: AS-IRB01-100070
First Posted: February 19, 2014    Key Record Dates
Last Update Posted: February 19, 2014
Last Verified: February 2014
Additional relevant MeSH terms:
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Warfarin
Atrial Fibrillation
Thrombosis
Venous Thrombosis
Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Anticoagulants