Clinical trial NCT02065388: Pharmacogenetic Dosing of Warfarin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stroke
Venous Thrombosis
Atrial Fibrillation
Atrial Flutter
Lead sponsor: Academia Sinica, Taiwan
Sponsor class: OTHER
Collaborators: name: Chang Gung Memorial Hospital
name: China Medical University Hospital
name: Kaohsiung Medical University
First posted: 2014-02-19
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Time spent in target INR range
timeFrame: first month of therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Institute of Biomedical Sciences, Academia Sinica
name: Ming Ta Michael Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.