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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02065388
Other study ID # AS-IRB01-100070
Secondary ID
Status Completed
Phase Phase 3
First received February 9, 2014
Last updated February 16, 2014
Start date September 2009
Est. completion date December 2013

Study information

Verified date February 2014
Source Academia Sinica, Taiwan
Contact n/a
Is FDA regulated No
Health authority Taiwan: Ministry of Health and Welfare
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Behavioral:
Standard of care dosing for warfarin

Genetic:
Genotype-guided dosingTaiwan algorithm for warfarin

Genotype-guided dosing IWPC algorithm for warfarin


Locations

Country Name City State
Taiwan Kaohsiung Medical University Kaohsiung
Taiwan China Medical University Hospital Taichung
Taiwan Chang Gung Memorial Hospital Taoyuan

Sponsors (4)

Lead Sponsor Collaborator
Academia Sinica, Taiwan Chang Gung Memorial Hospital, China Medical University Hospital, Kaohsiung Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time spent in target INR range 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. first month of therapy Yes
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