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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014