AgedINR-Cap piloteNCT02614573
International Normalised Ratio Evaluation by Generalist Practitioners in Full-time Care Establishments for the Elderly
A study testing CoagucheckXSR Capillary INR measures in people with Aged and Nursing Homes, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The main objective of this study is to evaluate, for a 6-month observation period, the concordance in terms of clinical decision making concerning therapeutic adjustment as determined by a weekly capillary International Normalised Ratio (INR) monitoring strategy versus the usual strategy in a population of dependent… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aged, Nursing Homes
- What is being tested?
- CoagucheckXSR Capillary INR measures
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2016to 13 Aug 2016
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The patient resides at the establishment for the dependent elderly (nursing home (EHPAD)) in Pont-Saint-Esprit, France
- The patient must be insured or beneficiary of a health insurance plan
- The patient treated with vitamin K antagonist for over six months
- The patient must have given his/her informed and signed consent
- For adults under guardianship, the legal guardian must have given free and informed consent and signed the consent
Who cannot join
- The patient is under judicial protection
- The general practitioner in charge of the patient at the EHPAD does not want to participate in the study
- It is impossible to correctly inform the patient, or his/her legal guardian
- The patient, or his/her legal guardian, refuses to sign the consent
- The patient is participating in another interventional study, or has participated in another interventional study within the past three months
- The patient is in an exclusion period determined by a previous study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: International Normalised Ratio Evaluation by Generalist Practitioners in Full-time Care Establishments for the Elderly: a Pilot Study
The main objective of this study is to evaluate, for a 6-month observation period, the concordance in terms of clinical decision making concerning therapeutic adjustment as determined by a weekly capillary International Normalised Ratio (INR) monitoring strategy versus the usual strategy in a population of dependent elderly people in nursing homes, treated with anti-vitamin K (AVK).
Read the detailed description
The secondary objectives of this study are to:
- Estimate the intra-patient variability of capillary INR measures.
- Estimate the time spent in the target INR (TTR) window of dependent elderly patients in nursing homes, under AVK treatment, and with a capillary INR monitoring strategy.
- Estimate the number of venous thromboembolic events and bleeding events over the 6-month observation period.
- Conditions
- Aged, Nursing Homes
- Being tested
- CoagucheckXSR Capillary INR measures
- Keywords
- Dependent, Aged, 80 and over, Aged
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoagucheckXSR Capillary INR measuresDevice
Also called CoagucheckXSR
We will be using the CoagucheckXSR device for capillary INR measures performed by nurses every 7 days during the 6 months of the study, plus after related intercurrent events.
If capillary INR is <2 or >3 (with a tolerance of 1.9 to 3.1 given the margin of measurement inaccuracy of the coagulometer), then a classic venous measure is performed. If both tests agree, adaptation of treatment as indicated. If slightly discordant results, then the INR values are considered discordant and the decision to adjust the treatment dose and the next monitoring date for venous INR is made based on the value of the venous INR, according to the predefined protocol. If clinically significant discordance (> 0.3), a venous INR is reperformed within 24 hours and if the discrepancy persists, dose adjustment is made according to the venous INR and the predefined protocol.
If capillary INR is > 4, then verification by venous measure and refer to general practitioner.
| Study group | Role | What they receive |
|---|---|---|
| The study population | Experimental | The clinical phases of this study will be held in the nursing home (EHPAD; principal building + 2 annexes) of Pont-Saint-Esprit, located in France. Patients are elderly dependents treated by anti-vitamin K for more than 6 months. Receives: Device: CoagucheckXSR Capillary INR measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Is the capillary INR concordant with the venous INR ? yes/no
Primary Outcome Measure as stated in protocol: Clinical concordances and clinical discrepancies between the capillary INR and venous INR every time they are concomitant
Measured: 6 months
Secondary outcomes (5)
The number of thromboembolic events per patient
Measured: 6 months
The number of bleeding events per patient
Measured: 6 months
The number of thromboembolic or bleeding events per patient
Measured: 6 months
Coefficient of variation for capillary INR measures per patient
Measured: 6 months
Time in therapeutique range (days)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2015 (estimated)
- Study startFeb 2016
- Primary completion13 Aug 2016
- Study completion13 Aug 2016
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 AgedStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chloé Sikirdji, Interne, Study director, Centre Hospitalier Universitaire de NīmesJean-François Clape, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02614573
- Sponsor's protocol ID
- LOCAL/2015/CS-01
- Other IDs
- 2015-A01056-43
- Acronym
- INR-Cap pilote
- Status last verified
- Aug 2016
- First submitted
- 19 Nov 2015
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Sikirdji C, Costa D, Alonso S, Clape JF, Amouyal M, de Waziere B, Fabbro-Peray P. Assessment of agreement and time in therapeutic range of capillary versus venous international normalised ratio in frail elderly people in a nursing home. Intern Med J. 2019 Nov;49(11):1442-1446. doi: 10.1111/imj.14626.
PubMed 31713344
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Normalised Ratio Evaluation by Generalist Practitioners in Full-time Care Establishments for the Elderly: a Pilot Study
- ClinicalTrials.gov ID
- NCT02614573
- Acronym / sponsor ID
- INR-Cap pilote / LOCAL/2015/CS-01
- Conditions
- Aged, Nursing Homes
- Keywords
- Dependent, Aged, 80 and over, Aged
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- 13 Aug 2016 (actual)
- Study completion
- 13 Aug 2016 (actual)
- First posted
- 25 Nov 2015 (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 main objective of this study is to evaluate, for a 6-month observation period, the concordance in terms of clinical decision making concerning therapeutic adjustment as determined by a weekly capillary International Normalised Ratio (INR) monitoring strategy versus the usual strategy in a population of dependent elderly people in nursing homes, treated with anti-vitamin K (AVK).
Detailed description
The secondary objectives of this study are to:
- Estimate the intra-patient variability of capillary INR measures.
- Estimate the time spent in the target INR (TTR) window of dependent elderly patients in nursing homes, under AVK treatment, and with a capillary INR monitoring strategy.
- Estimate the number of venous thromboembolic events and bleeding events over the 6-month observation period.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The study population | Experimental | Device: CoagucheckXSR Capillary INR measuresThe clinical phases of this study will be held in the nursing home (EHPAD; principal building + 2 annexes) of Pont-Saint-Esprit, located in France. Patients are elderly dependents treated by anti-vitamin K for more than 6 months. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- The patient resides at the establishment for the dependent elderly (nursing home (EHPAD)) in Pont-Saint-Esprit, France
- The patient must be insured or beneficiary of a health insurance plan
- The patient treated with vitamin K antagonist for over six months
- The patient must have given his/her informed and signed consent
- For adults under guardianship, the legal guardian must have given free and informed consent and signed the consent
Key exclusion criteria (6 listed)
- The patient is under judicial protection
- The general practitioner in charge of the patient at the EHPAD does not want to participate in the study
- It is impossible to correctly inform the patient, or his/her legal guardian
- The patient, or his/her legal guardian, refuses to sign the consent
- The patient is participating in another interventional study, or has participated in another interventional study within the past three months
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 |
|---|---|---|
| CoagucheckXSR Capillary INR measuresAlso: CoagucheckXSRWe will be using the CoagucheckXSR device for capillary INR measures performed by nurses every 7 days during the 6 months of the study, plus after related intercurrent events. If capillary INR is <2 or >3 (with a tolerance of 1.9 to 3.1 given the margin of measurement inaccuracy of the coagulometer), then a classic venous measure is performed. If both tests agree, adaptation of treatment as indicated. If slightly discordant results, then the INR values are considered discordant and the decision to adjust the treatment dose and the next monitoring date for venous INR is made based on the value of the venous INR, according to the predefined protocol. If clinically significant discordance (> 0.3), a venous INR is reperformed within 24 hours and if the discrepancy persists, dose adjustment is made according to the venous INR and the predefined protocol. If capillary INR is > 4, then verification by venous measure and refer to general practitioner. | Device | The study population |
Primary outcome
Is the capillary INR concordant with the venous INR ? yes/no
Time frame: 6 months
Primary Outcome Measure as stated in protocol: Clinical concordances and clinical discrepancies between the capillary INR and venous INR every time they are concomitant
5 secondary outcomes
The number of thromboembolic events per patient
Time frame: 6 months
The number of bleeding events per patient
Time frame: 6 months
The number of thromboembolic or bleeding events per patient
Time frame: 6 months
Coefficient of variation for capillary INR measures per patient
Time frame: 6 months
Time in therapeutique range (days)
Time frame: 6 months
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 19 Nov 2025.
- Results publication: PubMed 31713344Sikirdji C, Costa D, Alonso S, Clape JF, Amouyal M, de Waziere B, Fabbro-Peray P. Assessment of agreement and time in therapeutic range of capillary versus venous international normalised ratio in frail elderly people in a nursing home. Intern Med J. 2019 Nov;49(11):1442-1446. doi: 10.1111/imj.14626.
- Individual participant dataSharing planned: No
Related trials for Aged
RecruitingPhase 1
A Clinical Study of Letermovir (MK-8228) in Children and Adolescents Who Receive a Kidney Transplant (KT) (MK-8228-077)
Cytomegalovirus Prophylaxis
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
RecruitingPhase 3
A Study to Learn About a Clostridioides Difficile Vaccine in People 65 Years of Age and Older
Clostridoides Difficile Associated Disease
Active, not recruitingPhase 4
A Study About the Safety of ASP3021 Eye Injections and if They Help People in Japan With Vision Loss From Age-related Macular Degeneration
Geographic Atrophy, Age-Related Macular Degeneration
Recruiting
Effects of Doll Therapy on Apathy and Activities of Daily Living Initiation Deficits in Older Adults With Dementia
Dementia
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.
Chloé Sikirdji, Interne study director
Centre Hospitalier Universitaire de Nīmes
Jean-François Clape, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CoagucheckXSR Capillary INR measures in people with Aged and Nursing Homes, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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 5 inclusion and 6 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 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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?
Is the capillary INR concordant with the venous INR ? yes/no (time frame: 6 months). 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 NCT02614573, 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 19 Nov 2025.