Patient International Normalised Ratio (INR) Self-Testing Program - Full Text View

Sponsor:	University Hospital, Clermont-Ferrand
Collaborators:	St. Jude Medical Roche Diagnostics Mannheim HemoSense
Information provided by:	University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:	NCT00925197

Purpose

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.

Condition	Intervention	Phase
Mechanical Aortic and/or Mitral Valve Replacement Operation	Other: INR self-testing program	Phase III

Study Type:	Interventional
Study Design:	Randomized, Open Label
Official Title:	Patient INR Self-Testing Program Improves the Quality of Oral Anticoagulant Therapy After Mechanical Heart Valve Replacement

Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:

Hemorrhagic events and thromboembolic events [ Time Frame: after mechanical heart valve replacement ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Correlation of laboratory INR and device INR control [ Time Frame: after mechanical heart valve replacement ] [ Designated as safety issue: Yes ]

Enrollment:	206
Study Start Date:	May 2004
Study Completion Date:	January 2009
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

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).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00925197

Sponsors and Collaborators

University Hospital, Clermont-Ferrand

St. Jude Medical

Roche Diagnostics Mannheim

HemoSense

Investigators

Principal Investigator:

Kasra Azarnoush, MD

University Hospital, Clermont-Ferrand

More Information

No publications provided

Responsible Party:	CHU Clermont-Ferrand ( Patrick Lacarin )
Study ID Numbers:	CHU-0054
Study First Received:	June 18, 2009
Last Updated:	June 19, 2009
ClinicalTrials.gov Identifier:	NCT00925197 History of Changes
Health Authority:	France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:

anticoagulation
fluindione
patient self-testing

coaguchek
inratio
Post operative antivitamin K therapy

ClinicalTrials.gov processed this record on February 08, 2010