Patient International Normalised Ratio (INR) Self-Testing Program

This study has been completed.
Sponsor:
Collaborators:
St. Jude Medical
Roche Diagnostics Mannheim
HemoSense
Information provided by:
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT00925197
First received: June 18, 2009
Last updated: June 19, 2009
Last verified: June 2009
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Official Title: Patient INR Self-Testing Program Improves the Quality of Oral Anticoagulant Therapy After Mechanical Heart Valve Replacement

Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • Hemorrhagic events and thromboembolic events [ Time Frame: after mechanical heart valve replacement ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Correlation of laboratory INR and device INR control [ Time Frame: after mechanical heart valve replacement ] [ Designated as safety issue: Yes ]

Enrollment: 206
Study Start Date: May 2004
Study Completion Date: January 2009
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00925197

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

No publications provided by University Hospital, Clermont-Ferrand

Additional 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
Study First Received: June 18, 2009
Last Updated: June 19, 2009
Health Authority: France: Ministry of Health

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

ClinicalTrials.gov processed this record on April 15, 2014