Patient International Normalised Ratio (INR) Self-Testing Program

Study Overview
=================
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).

Official Title
-----------------
Patient INR Self-Testing Program Improves the Quality of Oral Anticoagulant Therapy After Mechanical Heart Valve Replacement

Conditions
-----------------
Mechanical Aortic and/or Mitral Valve Replacement Operation

Intervention / Treatment
-----------------
* Other: INR self-testing program


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: INR self-testing program|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemorrhagic events and thromboembolic events |  | after mechanical heart valve replacement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of laboratory INR and device INR control |  | after mechanical heart valve replacement | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anticoagulation, fluindione, patient self-testing, coaguchek, inratio, Post operative antivitamin K therapy