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Patient International Normalised Ratio (INR) Self-Testing Program

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ClinicalTrials.gov Identifier: NCT00925197
Recruitment Status : Completed
First Posted : June 22, 2009
Last Update Posted : June 22, 2009
Sponsor:
Collaborators:
St. Jude Medical
Roche Diagnostics
HemoSense
Information provided by:
University Hospital, Clermont-Ferrand

Brief 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.

Condition or disease Intervention/treatment Phase
Mechanical Aortic and/or Mitral Valve Replacement Operation Other: INR self-testing program Phase 3

Detailed Description:

This is the first French, prospective, randomised, single centre study, comparing patient self-testing (PST) of international normalised ratio (INR), with conventional laboratory monitoring. Aims of the study are to prove correlation between laboratory and PST measurements, estimation of INR variability within a target therapeutic zone and frequency of hemorrhagic and/or thromboembolic events after mechanical heart valve replacement.

Patients (206) were postoperatively, randomly, consecutively included (2004 - 2008): 103 patients in each group, with a one year follow-up. Two INR control devices were selected: Coaguchek® (Roche) and INRATIO® (Hemosense).


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 206 participants
Allocation: Randomized
Masking: None (Open Label)
Official Title: Patient INR Self-Testing Program Improves the Quality of Oral Anticoagulant Therapy After Mechanical Heart Valve Replacement
Study Start Date : May 2004
Actual Primary Completion Date : September 2008
Actual Study Completion Date : January 2009



Primary Outcome Measures :
  1. Hemorrhagic events and thromboembolic events [ Time Frame: after mechanical heart valve replacement ]

Secondary Outcome Measures :
  1. Correlation of laboratory INR and device INR control [ Time Frame: after mechanical heart valve replacement ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • adults
  • patients fitted with one or more mechanical heart valves either alone or in combination with myocardial revascularization
  • oral anticoagulant treatment
  • patients with social security cover
  • written informed consent signed by both patient and investigator
  • able to be followed up during 12 months

Exclusion Criteria:

  • refusal of participation in the study
  • Participation in another clinical study
  • Patient is pregnant or nursing
  • Life expectancy less than three months
  • Contra-indication of to an A.V.K treatment
  • Difficult comprehension of the French language
  • Patients unable to master the self-monitoring procedures
  • Individuals under judicial control or enquiry
  • Patients on dialysis Patients with incomplete understanding of instructions
  • Blind patients and those unable to read

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00925197


Sponsors and Collaborators
University Hospital, Clermont-Ferrand
St. Jude Medical
Roche Diagnostics
HemoSense
Investigators
Principal Investigator: Kasra Azarnoush, MD University Hospital, Clermont-Ferrand

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Patrick Lacarin, CHU Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT00925197     History of Changes
Other Study ID Numbers: CHU-0054
First Posted: June 22, 2009    Key Record Dates
Last Update Posted: June 22, 2009
Last Verified: June 2009

Keywords provided by University Hospital, Clermont-Ferrand:
anticoagulation
fluindione
patient self-testing
coaguchek
inratio
Post operative antivitamin K therapy