Status:
COMPLETED
Patient International Normalised Ratio (INR) Self-Testing Program
Lead Sponsor:
University Hospital, Clermont-Ferrand
Collaborating Sponsors:
Abbott Medical Devices
Roche Diagnostics GmbH
Conditions:
Mechanical Aortic and/or Mitral Valve Replacement Operation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 hemorrhag...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
206 Patients enrolled
Trial Details
Trial ID
NCT00925197
Start Date
May 1 2004
End Date
January 1 2009
Last Update
June 22 2009
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