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Patient Self Testing of Warfarin Therapy

NCT00594828 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 163

Last updated 2008-01-16

No results posted yet for this study

Summary

To test the hypothesis that home international normalised ratio (INR) monitoring with supervised patient self-testing (PST)can provide comparable or superior time in therapeutic range (TTR) to that provided by traditional outpatient anticoagulation.

Conditions

  • Warfarin

Interventions

DEVICE

CoaguChek (Patient self testing)

Patients will test their INR at home either biweekly, weekly or every 2 weeks using a CoaguChek point of care meter and communicate with the healthcare provider via an internet based expert system

DEVICE

Anticoagulation Management Service (AMS)

Patients will attend the AMS for six months and have their INR checked every 4-6 weeks or more frequently, at the discretion of the clinician

Sponsors & Collaborators

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • Health Research Board, Ireland

    collaborator OTHER

  • ZyCare Inc

    collaborator INDUSTRY

  • University College Cork

    lead OTHER

Principal Investigators

  • Susan J O'Shea, MD · Cork University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2009-04-30
Completion
2008-04-30

Countries

  • Ireland

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00594828 on ClinicalTrials.gov