CClinicalTrials.gg
Status unknownNCT01972971Updated Oct 31, 2013

To Establish a Novel Prototype of Clinical Pharmacy Services by Warfarin Consultation in a Pharmacist Clinic

An interventional study of patient education in Intentional Warfarin Sodium Overdose, sponsored by National Taiwan University Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2013-10-31.

Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Health services research

The sponsor has not verified this record recently (last verified Oct 2013), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Not applicable
Ages
20 Years and older
Sex
All
01

Study summary

Warfarin, the major oral anticoagulant currently available in Taiwan, is used for the prevention and treatment of a variety of thromboembolic disorders. Under dosing of warfarin may cause treatment failure and over dosing may cause bleeding because of its narrow therapeutic index. Therefore, it is important to monitor prothrombin time (PT) and international normalize ratio (INR) periodically in order to evaluate the appropriateness of warfarin dosing.

Lots of factors influencing warfarin anticoagulation effects include polymorphisms of Cytochrome P450 2C9(CYP2C9)and Vitamin K epoxide reductase complex subunit 1(VKORC1)genes, age, weight, diet and concurrent medications. Taking into consideration of physicians' work load, pharmacist-managed anticoagulation clinics were set up to help strengthen patient care in US to ensure patient medication safety. In addition, differences in genetic polymorphisms between Chinese and Caucasian have great impacts on warfarin dosage, and there is still no consensus on warfarin utilization guideline in Taiwan. Pharmacist-managed anticoagulation clinics provide individualized care, consistent monitoring and patient education. Through this service, physicians can get the latest integrated information about their patients, patients themselves are more familiar with their medication, and adherence can be improved. Therefore, those who take warfarin will get better INR control, less adverse drug-related events and treatment failure.

This is the first prototype of pharmacist clinic for a specific medication in our hospital. The adverse drug events and coagulation function data collected through this program can be used for the implementation of warfarin treatment guideline in Taiwan in the future. The impact of pharmacist clinic can be evaluated by questionnaire of satisfaction and knowledge survey. It can be used as a model for implementing other pharmacist-managed clinics and improving patient medication safety.

02

Conditions studied

  • Intentional Warfarin Sodium Overdose

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Keywords

  • warfarin
  • pharmacist
  • anticoagulation
03

In context

Drug Overdose

139 studies on the registry are indexed under Drug Overdose; 24 are open to participants now.

This study's planned enrollment of 300 is above the median of 100 across 98 interventional studies indexed under Drug Overdose.

Browse Drug Overdose studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • >20 y/o
  • Has been received warfarin therapy for 3 months and anticipated treatment duration of more than 3 months and a week
  • Has legitimate indication for warfarin
  • Has the capacity to understand the condition and implications of anticoagulant therapy

Exclusion criteria

Exclusion Criteria:

  • Who can't be regular follow-up at National Taiwan University Hospital.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • Other
    pharmacist care

    Other: patient education

Interventions

  • Otherpatient education

    one by one patient education

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What researchers measure

Primary outcomes

  1. percentage of INR in therapeutic range and incidence of complications

    The INR value collected during the 3 months before enrollment and within 3 months after enrollment, which was proceeded by the one month wash-out period. The bleeding or thromboembolic events during this period were also collected. The outcome was assessed by the percentage of patient time with INR within the target range (1.8-2.4) and incidence of complications.

    Time frame: 3 months

Secondary outcomes

  1. patient's warfarin knowledge improvement

    Patient's warfarin-related knowledge would be assessed by questionnaire. The validity of the questionnaire were assessed by experts. This questionnaire contained 9 aspects. the pre-test of warfarin-related knowledge questionnaire was conducted before patient education, and the post-test was conducted 2 months after enrollment in the pharmacist clinic. The correct percentage between pre-test and post-test would be compared.

    Time frame: 3 months

  2. Patient's satisfaction to anticoagulation pharmacist clinic

    Patient's satisfaction would be assessed by questionnaire. The validity of the questionnaire was assessed by experts. The per-test was conducted before the patient enrolled to pharmacist clinic, and the post-test was conducted 2 months after enrollment. The difference between pre-test and post-test would be evaluated.

    Time frame: 3 months

07

Study locations

1 of 1 sites recruiting
  • National Taiwan University Hospital
    Taipei, 10051, Taiwan
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 31, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01972971
Lead sponsor
National Taiwan University Hospital
Responsible party
Sponsor
First posted
Oct 31, 2013
Start date
Feb 2012
Primary completion
Jul 2016 (estimated)
Completion
Jul 2016 (estimated)
Last update
Oct 31, 2013

Study contacts

Fe-Lin L L WU, PHD
Contact
flwu@ntu.edu.tw
886-2-23123456 ext. 88389
Fe-Lin L WU, PhD
principal investigator · National Taiwan University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.

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