Patient International Normalised Ratio (INR) Self-Testing Program

June 19, 2009 updated by: University Hospital, Clermont-Ferrand

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

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.

Study Overview

Status

Completed

Conditions

Mechanical Aortic and/or Mitral Valve Replacement Operation

Intervention / Treatment

Other: INR self-testing program

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 Type

Interventional

Enrollment (Actual)

206

Phase

Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Allocation: Randomized
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Hemorrhagic events and thromboembolic events Time Frame: after mechanical heart valve replacement	after mechanical heart valve replacement

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Collaborators

Abbott Medical Devices

Roche Diagnostics

HemoSense

Investigators

Principal Investigator: Kasra Azarnoush, MD, University Hospital, Clermont-Ferrand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

June 18, 2009

First Submitted That Met QC Criteria

June 19, 2009

First Posted (Estimate)

June 22, 2009

Study Record Updates

Last Update Posted (Estimate)