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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

June 18, 2009
June 19, 2009
May 2004
September 2008   (final data collection date for primary outcome measure)
Hemorrhagic events and thromboembolic events [ Time Frame: after mechanical heart valve replacement ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00925197 on ClinicalTrials.gov Archive Site
Correlation of laboratory INR and device INR control [ Time Frame: after mechanical heart valve replacement ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Patient International Normalised Ratio (INR) Self-Testing Program
Patient INR Self-Testing Program Improves the Quality of Oral Anticoagulant Therapy After Mechanical Heart Valve Replacement

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.

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).

Interventional
Phase 3
Allocation: Randomized
Masking: Open Label
Mechanical Aortic and/or Mitral Valve Replacement Operation
Other: INR self-testing program
Not Provided
Azarnoush K, Dorigo E, Pereira B, Dauphin C, Geoffroy E, Dauphin N, D'Ostrevy N, Legault B, Camilleri L. Mid-term results of self-testing of the international normalized ratio in adults with a mechanical heart valve. Thromb Res. 2014 Feb;133(2):149-53. doi: 10.1016/j.thromres.2013.09.013. Epub 2013 Sep 16. PubMed PMID: 24112749.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
206
January 2009
September 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Not Provided
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00925197
CHU-0054
Not Provided
Patrick Lacarin, CHU Clermont-Ferrand
University Hospital, Clermont-Ferrand
  • St. Jude Medical
  • Roche Diagnostics Mannheim
  • HemoSense
Principal Investigator: Kasra Azarnoush, MD University Hospital, Clermont-Ferrand
University Hospital, Clermont-Ferrand
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP