Patient International Normalised Ratio (INR) Self-Testing Program

Phase 3

Completed

• Conditions: Mechanical Aortic and/or Mitral Valve Replacement Operation

• Registration Number: NCT00925197
• Lead Sponsor: University Hospital, Clermont-Ferrand

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).

Study Timeline

• Study Start: 2004-05
• Primary Completion: 2008-09
• Study Completion: 2009-01
• Status Verified: 2009-06
• Study First Submitted: 2009-06-18
• Study First Submitted QC: 2009-06-19
• Last Update Submitted: 2009-06-19
• Study First Posted: 2009-06-22
• Last Update Posted: 2009-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 206

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hemorrhagic events and thromboembolic events	after mechanical heart valve replacement

Secondary Outcome Measures

Name	Time	Method
Correlation of laboratory INR and device INR control	after mechanical heart valve replacement