- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00925197
Patient International Normalised Ratio (INR) Self-Testing Program
Patient INR Self-Testing Program Improves the Quality of Oral Anticoagulant Therapy After Mechanical Heart Valve Replacement
Study Overview
Status
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Investigators
- Principal Investigator: Kasra Azarnoush, MD, University Hospital, Clermont-Ferrand
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CHU-0054
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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