Patient International Normalised Ratio (INR) Self-Testing Program
Mechanical Aortic and/or Mitral Valve Replacement Operation
Other: INR self-testing program
|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|
- Hemorrhagic events and thromboembolic events [ Time Frame: after mechanical heart valve replacement ] [ Designated as safety issue: Yes ]
- Correlation of laboratory INR and device INR control [ Time Frame: after mechanical heart valve replacement ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2004|
|Study Completion Date:||January 2009|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00925197
|Principal Investigator:||Kasra Azarnoush, MD||University Hospital, Clermont-Ferrand|