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Patient International Normalised Ratio (INR) Self-Testing Program

NCT00925197 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 206

Last updated 2009-06-22

No results posted yet for this study

Summary

The aims of the study are to prove correlation between laboratory and patient self-testing (PST) measurements, estimation of INR variability within a target therapeutic zone and frequency of hemorrhagic and/or thromboembolic events after mechanical heart valve replacement.

Conditions

  • Mechanical Aortic and/or Mitral Valve Replacement Operation

Interventions

OTHER

INR self-testing program

Sponsors & Collaborators

  • Abbott Medical Devices

    collaborator INDUSTRY

  • Roche Diagnostics GmbH

    collaborator INDUSTRY

  • HemoSense

    collaborator INDUSTRY

  • University Hospital, Clermont-Ferrand

    lead OTHER

Principal Investigators

  • Kasra Azarnoush, MD · University Hospital, Clermont-Ferrand

Study Design

Allocation
RANDOMIZED
Masking
NONE

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-05-31
Primary Completion
2008-09-30
Completion
2009-01-31

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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 NCT00925197 on ClinicalTrials.gov