Clinical trial NCT00925197: Patient International Normalised Ratio (INR) Self-Testing Program
Official title: Patient INR Self-Testing Program Improves the Quality of Oral Anticoagulant Therapy After Mechanical Heart Valve Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Mechanical Aortic and/or Mitral Valve Replacement Operation
Keywords: anticoagulation
fluindione
patient self-testing
coaguchek
inratio
Post operative antivitamin K therapy
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Abbott Medical Devices
name: Roche Diagnostics GmbH
name: HemoSense
First posted: 2009-06-22
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED

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.

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 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

Primary outcomes:
measure: Hemorrhagic events and thromboembolic events
timeFrame: after mechanical heart valve replacement
Secondary outcomes:
measure: Correlation of laboratory INR and device INR control
timeFrame: after mechanical heart valve replacement
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Kasra Azarnoush, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.