Patient International Normalised Ratio (INR) Self-Testing Program

University Hospital, Clermont-Ferrand206 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

206

Conditions

Mechanical Aortic and/or Mitral Valve Replacement Operation

Interventions

INR self-testing programOTHER

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Hemorrhagic events and thromboembolic events

Time frame: after mechanical heart valve replacement

Secondary Outcomes

Correlation of laboratory INR and device INR control

Time frame: after mechanical heart valve replacement

Data from ClinicalTrials.gov

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