Mechanical Aortic and/or Mitral Valve Replacement OperationPhase 3NCT00925197
Patient International Normalised Ratio (INR) Self-Testing Program
A Phase 3 study testing INR self-testing program in people with Mechanical Aortic and/or Mitral Valve Replacement Operation, run by University Hospital, Clermont-Ferrand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Aortic and/or Mitral Valve Replacement Operation
- What is being tested?
- INR self-testing program
- How many people
- 206 participants
- Where
- No sites listed yet
- Study dates
- May 2004to Jan 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
About this study
Official title: 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.
Read the 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).
- Being tested
- INR self-testing program
- Keywords
- anticoagulation, fluindione, patient self-testing, coaguchek, inratio, Post operative antivitamin K therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INR self-testing programOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemorrhagic events and thromboembolic events
Measured: after mechanical heart valve replacement
Secondary outcomes (1)
Correlation of laboratory INR and device INR control
Measured: after mechanical heart valve replacement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2009 (estimated)
- Study startMay 2004
- Primary completionSep 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mechanical Aortic and/or Mitral Valve Replacement OperationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Allocation
- Randomised
- Masking
- None (open label)
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Medical Devices, Roche Diagnostics GmbH, HemoSense
- Investigators
- Kasra Azarnoush, MD, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00925197
- Sponsor's protocol ID
- CHU-0054
- Status last verified
- Jun 2009
- First submitted
- 18 Jun 2009
- Last updated
- 22 Jun 2009
- Results posted
- No
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.
PubMed 24112749
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient INR Self-Testing Program Improves the Quality of Oral Anticoagulant Therapy After Mechanical Heart Valve Replacement
- ClinicalTrials.gov ID
- NCT00925197
- Acronym / sponsor ID
- CHU-0054
- Keywords
- anticoagulation, fluindione, patient self-testing, coaguchek, inratio, Post operative antivitamin K therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Abbott Medical Devices, Roche Diagnostics GmbH, HemoSense
- Study start
- May 2004
- Primary completion
- Sep 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 22 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INR self-testing program | Other | – |
Primary outcome
Hemorrhagic events and thromboembolic events
Time frame: after mechanical heart valve replacement
1 secondary outcome
Correlation of laboratory INR and device INR control
Time frame: after mechanical heart valve replacement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2009.
- Derived from this study: PubMed 24112749Azarnoush 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kasra Azarnoush, MD principal investigator
University Hospital, Clermont-Ferrand
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing INR self-testing program in people with Mechanical Aortic and/or Mitral Valve Replacement Operation, run by University Hospital, Clermont-Ferrand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemorrhagic events and thromboembolic events (time frame: after mechanical heart valve replacement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00925197, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2009.