Patient International Normalised Ratio (INR) Self-Testing Program

University Hospital, Clermont-Ferrand

Status and phase: Completed; Phase 3

Conditions: Mechanical Aortic and/or Mitral Valve Replacement Operation

Treatments: Other: INR self-testing program

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00925197

CHU-0054

Details and patient eligibility

About

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.

Full 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).

Enrollment: 206 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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