Atrial FibrillationINR-CAPNCT05561244
Weekly Monitoring Strategy of Capillary INR Versus Monthly Monitoring Strategy of Venous INR in Elderly Patients in a Nursing Home.
A study testing Weekly monitoring using the capillary International Normalised Ratio strategy in people with Atrial Fibrillation and Deep Vein Thrombosis, run by Centre Hospitalier Universitaire de Nīmes at 33 sites in France.
Trial summary
This primary care study aims to compare the "time in therapeutic range" (TTR) of two strategies for monitoring the international normalized ratio (INR) over 6 months in nursing homes. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Atrial Fibrillation, Deep Vein Thrombosis, Stroke
- What is being tested?
- Weekly monitoring using the capillary International Normalised Ratio strategy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 33 sitesFrance
- Study dates
- 18 Nov 2022to 13 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- The patient is participating in a Type 1 interventional study involving human beings (Jardé law).
- The patient is in an exclusion period determined by another study
- The patient is under safeguard of justice.
- It is not possible to give the patient (or his/her trusted-person/legal representative/tutor) informed information.
- The patient has a short life expectancy (< 1 month)
- The Karnofky index is ≤ 20%
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
France33 sites
EHPAD " Coté Canal "
Aigues-Mortes, GARD, 30220
EHPAD "Samdo Rochebelle"
Alès, GARD, 30100
EHPAD "Docteur Henry Granet"
Aramon, GARD, 30390
EHPAD "Les Capitelles"
Bernis, GARD, 30620
EHPAD Résidence "Les Caprésianes"
Cabrières, GARD, 30210
EHPAD "Jean Lasserre"
Euzet, GARD, 30360
EHPAD "Les Jasses"
Fons, GARD, 30730
EHPAD "Les Dominicaines"
Ganges, Hérault, 34190
EHPAD "Les 5 sens Garons"
Garons, GARD, 30128
EHPAD du centre hospitalier de Langogne
Langogne, LOZERE, 48300
EHPAD La Murelle
Laurens, 34480
EHPAD Saint-Vincent de Paul
Le Grau-du-Roi, GARD, 30240
EHPAD Korian "Les Meunières"
Lunel, HERAULT, 34400
EHPAD "Sophia la Capitelle"
Meynes, GARD, 30840
EHPAD "Les oliviers"
Montfrin, GARD, 30490
EHPAD Malbosc
Montpellier, HERAULT, 34090
Maison de Retraite Protestante
Montpellier, Hérault, 34090
EHPAD "Les Monts d'Aurelle"
Montpellier, Hérault, 34097
Centre Bellevue-CHU Montpellier
Montpellier, 34090
EHPAD "Jacques Saurin"
Moussac, GARD, 30190
EHPAD "Ma Maison"
Nîmes, GARD, 30000
EHPAD Serre-Cavalier Sites 1 and 2
Nîmes, GARD, 30000
Nîmes University Hospital, Place du Pr. Debré
Nîmes, Gard, 30029
EHPAD "Korian Mas de Lauze"
Nîmes, 30900
EHPAD ORPEA "Château Notre Dame"
Parignargues, GARD, 30730
EHPAD "Villa Rediciano"
Redessan, GARD, 30129
SCM Médicale St Bauzille de Putois
Saint-Bauzille-de-Putois, HERAULT, 34190
EHPAD "La BELLE Viste"
Saint-Gély-du-Fesc, Hérault, 34980
EHPAD "Résidence les Magnans"
Saint-Martin-de-Valgalgues, GARD, 30520
EHPAD "Les Jardins de l'Escalette"
Uzès, GARD, 30700
EHPAD Résidence "l'Accueil"
Vauvert, GARD, 30600
EHPAD La Pinède
Vergèze, 30310
EHPAD Léon Bourgeois
Vilallonga dels Monts, 66740
About this study
Official title: Assessment of Weekly Monitoring Strategy of Capillary INR Versus Monthly Monitoring Strategy of Venous INR in Elderly Patients in a Nursing Home: Multicentre Randomised Cluster Trial.
This primary care study aims to compare the "time in therapeutic range" (TTR) of two strategies for monitoring the international normalized ratio (INR) over 6 months in nursing homes. The population consists of frail elderly patients for whom Anti-Vitamin K treatments are frequent, and who are consequently more prone to embolic and hemorrhagic complications.
Read the detailed description
Biological monitoring is essential to avoid strokes, deep vein thrombosis and hemorrhage. Generally speaking, this consists of a venous sampling for the international normalized ratio (INR), for which the therapeutic target is approximately 2.5 (tolerance range between 2 and 3) for atrial fibrillation (AF) and deep vein thrombosis (DVT). INR values below 2 indicate high risks of a stroke or DVT, whereas INR values over 3 refer to high risks of hemorrhage. INR monitoring requires monthly follow-ups or even more frequently if the HAS BLED score is ≥ 3.
One parameter used to evaluate the benefit/risk ratio is the "time in therapeutic range" (TTR), referring to the time spent within the INR therapeutic target (INR between 2 and 3 for patients with Atrial Fibrillation/ Deep Vein Thrombosis). It is calculated using the Rosendaal method. According to the "European Society of Cardiology" guidelines, the minimum threshold necessary for a good risk/benefit ratio is 70%. In other countries, it has been shown that the TTR is higher: 61% in Canada, 64.4% in Spain, 68.9% in Italy and 76.2% in Sweden. Moreover, TTR determines the benefit/risk ratio of the treatment, which means that patients with a TTR < 60% have more than 2% absolute total mortality per patient-year compared to patients with TTR > 60%.
As for the pilot study (Manuscript accepted in August 2019 in the Journal of Internal Medicine ), we expect approximately half the patients to be aged over 90. Patients will be recruited in nursing homes where they are monitored by nurses and care quality managers who are responsible for ensuring compliance with good clinical practices. This limits the risk of non-compliance with preanalytical venous INR conditions. Eighteen percent of subjects over 85 are treated with vitamin-K antagonists (VKA). For elderly patients with atrial fibrillation (AF) or deep venous thrombosis (DVT), stroke prophylaxis is a real clinical challenge. VKA treatments are indicated for the prevention of strokes in patients with Atrial Fibrillation, DVT or those who have received heart valve implants. VKAs have a narrow therapeutic range: if they are under-dosed, the risk of embolism (AVC and DVT) is high, whereas in the event of an overdose, the risk of bleeding is high. Given the annual incidence of severe hemorrhage (3-5%), the risk of a hemorrhage is their main side effect. The incidence of brain hemorrhages is 0.6 per 100 patient-years, for gastrointestinal bleeding it is 1.0 per 100 patient-years, and the risk of other serious bleeding is 1.4 per 100 patient-years. This risk of bleeding is usually assessed using the HAS-BLED score. The risk of hemorrhage is 4.2% per year in patients over 75 versus 1.7% per year for those under 75.
Following the results of a pilot study (manuscript accepted in the Journal of Internal Medecine), the hypothesis is that a weekly monitoring strategy for capillary INR should increase the TTR of nursing home patients by 12% compared to the usual monitoring by venous INR, resulting in a decrease of thrombotic or hemorrhagic events.
- Conditions
- Atrial Fibrillation, Deep Vein Thrombosis, Stroke
- Being tested
- Weekly monitoring using the capillary International Normalised Ratio strategy
- Keywords
- Atrial Fibrillation, Thrombosis, Stroke, Elderly
- Medical subject headings
- Atrial Fibrillation, Venous Thrombosis, Stroke, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weekly monitoring using the capillary International Normalised Ratio strategyDevice
Patients in the interventional group will be monitored using the capillary International Normalised Ratio strategy every week, and more often if the International Normalised Ratio is not in the therapeutic target. Venous International Normalised Ratio punctures will also be performed as described for the control group in order to calculate the Time in Therapeutic Range equivalently in both groups. Specific training in handling the device and the dose adjustment protocol will be provided to nurses and prescribers.
| Study group | Role | What they receive |
|---|---|---|
| CONTROL GROUP | No intervention | Control group (n = 16 nursing homes, 64 patients): Patients will be monitored as usual using the Venous International Normalised Ratio strategy. Practices will not be changed (i.e. prospective observation of real-life practices; according to recommendations, at least 1 Venous International Normalised Ratio per month will usually be performed) and patients will not receive any supplementary intervention specific to the trial. A reminder of good International Normalised Ratio practices will be provided to nurses and prescribers. |
| INTERVENTIONAL GROUP | Experimental | Intervention group (n = 16 nursing homes, 64 patients): Patients in the interventional group will be monitored using the capillary International Normalised Ratio strategy every week, and more often if the International Normalised Ratio is not in the therapeutic target. Venous International Normalised Ratio punctures will also be performed as described for the control group in order to calculate the Time in Therapeutic Range equivalently in both groups. Specific training in handling the device and the dose adjustment protocol will be provided to nurses and prescribers. Receives: Device: Weekly monitoring using the capillary International Normalised Ratio strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in Therapeutic Range Using the Capillary International Normalized Range Weekly Monitoring Strategy
The CoaguChek INRange® device will be used. This small, portable monitoring medical device has already been used in several studies and can be used in hospital beds. After washing the patient's hands, the nurse will insert the strip test into the device, massaging the fingers and hand to activate blood circulation, and perform a capillary puncture using the lancet. An 8 μL drop of blood is required and must be deposited on the test strip less than 180 seconds after inserting the strip into the device and within 15 seconds after the start of blood drop formation. The International Normalized Ratio is displayed within one minute. When the nurse has the result, he/she will complete the VKA dose software (i.e. puncture number, strip number, current VKA type, current VKA dose, INRc value). The software will give the next puncture day and the correct VKA dose. If the INR > 4, there will be an alert and the nurse will have to contact the general practitioner for the rest of the procedure.
Measured: Over 6 months
Secondary outcomes (6)
Venous Thromboembolic Events Occurring During the 6-month Monitoring Period.
Venous thromboembolic events (yes / no) occurring during the 6-month monitoring period will be recorded for each patient.
Measured: Day 0 to Month 6
Haemorrhagic Events Occurring During the 6-month Monitoring Period.
Haemorrhagic events (yes / no) occurring during the 6-months monitoring period will be recorded for each patient.
Measured: Day 0 to Month 6
Time in Therapeutic Range Using International Normalized Range Weekly Monitoring Strategy in Patients ≤90.
Percentage of Time in Therapeutic Range using International Normalized Range weekly monitoring strategy in patients ≤90.
Measured: Day 0 to 6 months
Time in Therapeutic Range Using the International Normalized Range Weekly Monitoring Strategy in Patients >90.
Time in Therapeutic Range using the International Normalized Range weekly monitoring strategy in patients >90.
Measured: Day 0 to 6 months
Cost-consequences Study on the Weekly INRc Monitoring Strategy
Cost in terms of hospitalisations (due to haemorrhagic, ischemic and thromboembolic events) will be studied including the cost of the device (equipment and consumables) from the public health insurance's perspective and the nursing time from the point of view of the health care institution.
Measured: Day 0 to 6 months
Agreement Between Capillary and Veinous Measures
Assess, over the 6-month observation period, the agreement between INRc and INRv
Measured: Over 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start18 Nov 2022
- Primary completion13 Dec 2024
- Study completion13 Dec 2024
Why it stopped: In the absence of patients meeting the selection criteria, the study was prematurely terminated. The average number of patients on VKAs per EHPAD has fallen sharply because of the development of direct oral anticoagulants and the Covid crisis.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is interventional, prospective, comparative, superiority, multicentric, randomised by cluster, in closed cohort.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chloé SIKIRDJI, Dr., Principal investigator, CHU de Nîmes (NUH) Place du Pr. Debré 30029 NIMES Cedex9Karen ZERBIB, Dr., Principal investigator, EHPAD "Korian Mas de Lauze", 17, Chemin du puits de Louiset 30900 NIMESPatrick DUTILLEUL, Dr., Principal investigator, EHPAD Résidence "l'Accueil", 75 Rue Louis Aragon, 30600 VAUVERTAlain BROUSSE, Dr., Principal investigator, EHPAD "Les Jardins de l'Escalette",1 Avenue Marechal Foch 30700 UZESElodie MILLION, Dr., Principal investigator, EHPAD Malbosc, 345 Avenue de Fes 34090 MONTPELLIERPhilippe SERAYET, Dr., Principal investigator, EHPAD "Sophia la Capitelle", 57 Rue Henri Pitot 30840 MEYNESThierry CORNILLE, Dr., Principal investigator, EHPAD "Docteur Henry Granet", 23 Chemin de la grave 30390 ARAMON +EHPAD "Les oliviers", 420 Chem. de Ceserac 30490 MONTFRINGilles SEYLER, Dr., Principal investigator, EHPAD "les Caprésianes",111 r. Alphonse Daudet 30210 CABRIERES, "Villa Rediciano", 6 r. du 19 Mars 1962, 30129 REDESSAN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05561244
- Sponsor's protocol ID
- 2022-A00516-37
- Acronym
- INR-CAP
- Status last verified
- Dec 2024
- First submitted
- 27 Sep 2022
- Last updated
- 3 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Weekly Monitoring Strategy of Capillary INR Versus Monthly Monitoring Strategy of Venous INR in Elderly Patients in a Nursing Home: Multicentre Randomised Cluster Trial.
- ClinicalTrials.gov ID
- NCT05561244
- Acronym / sponsor ID
- INR-CAP / 2022-A00516-37
- Conditions
- Atrial Fibrillation, Deep Vein Thrombosis, Stroke
- Keywords
- Atrial Fibrillation, Thrombosis, Stroke, Elderly
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: In the absence of patients meeting the selection criteria, the study was prematurely terminated. The average number of patients on VKAs per EHPAD has fallen sharply because of the development of direct oral anticoagulants and the Covid crisis.
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 18 Nov 2022 (actual)
- Primary completion
- 13 Dec 2024 (actual)
- Study completion
- 13 Dec 2024 (actual)
- First posted
- 30 Sep 2022 (actual)
- Results
- Posted 3 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This primary care study aims to compare the "time in therapeutic range" (TTR) of two strategies for monitoring the international normalized ratio (INR) over 6 months in nursing homes. The population consists of frail elderly patients for whom Anti-Vitamin K treatments are frequent, and who are consequently more prone to embolic and hemorrhagic complications.
Detailed description
Biological monitoring is essential to avoid strokes, deep vein thrombosis and hemorrhage. Generally speaking, this consists of a venous sampling for the international normalized ratio (INR), for which the therapeutic target is approximately 2.5 (tolerance range between 2 and 3) for atrial fibrillation (AF) and deep vein thrombosis (DVT). INR values below 2 indicate high risks of a stroke or DVT, whereas INR values over 3 refer to high risks of hemorrhage. INR monitoring requires monthly follow-ups or even more frequently if the HAS BLED score is ≥ 3.
One parameter used to evaluate the benefit/risk ratio is the "time in therapeutic range" (TTR), referring to the time spent within the INR therapeutic target (INR between 2 and 3 for patients with Atrial Fibrillation/ Deep Vein Thrombosis). It is calculated using the Rosendaal method. According to the "European Society of Cardiology" guidelines, the minimum threshold necessary for a good risk/benefit ratio is 70%. In other countries, it has been shown that the TTR is higher: 61% in Canada, 64.4% in Spain, 68.9% in Italy and 76.2% in Sweden. Moreover, TTR determines the benefit/risk ratio of the treatment, which means that patients with a TTR < 60% have more than 2% absolute total mortality per patient-year compared to patients with TTR > 60%.
As for the pilot study (Manuscript accepted in August 2019 in the Journal of Internal Medicine ), we expect approximately half the patients to be aged over 90. Patients will be recruited in nursing homes where they are monitored by nurses and care quality managers who are responsible for ensuring compliance with good clinical practices. This limits the risk of non-compliance with preanalytical venous INR conditions. Eighteen percent of subjects over 85 are treated with vitamin-K antagonists (VKA). For elderly patients with atrial fibrillation (AF) or deep venous thrombosis (DVT), stroke prophylaxis is a real clinical challenge. VKA treatments are indicated for the prevention of strokes in patients with Atrial Fibrillation, DVT or those who have received heart valve implants. VKAs have a narrow therapeutic range: if they are under-dosed, the risk of embolism (AVC and DVT) is high, whereas in the event of an overdose, the risk of bleeding is high. Given the annual incidence of severe hemorrhage (3-5%), the risk of a hemorrhage is their main side effect. The incidence of brain hemorrhages is 0.6 per 100 patient-years, for gastrointestinal bleeding it is 1.0 per 100 patient-years, and the risk of other serious bleeding is 1.4 per 100 patient-years. This risk of bleeding is usually assessed using the HAS-BLED score. The risk of hemorrhage is 4.2% per year in patients over 75 versus 1.7% per year for those under 75.
Following the results of a pilot study (manuscript accepted in the Journal of Internal Medecine), the hypothesis is that a weekly monitoring strategy for capillary INR should increase the TTR of nursing home patients by 12% compared to the usual monitoring by venous INR, resulting in a decrease of thrombotic or hemorrhagic events.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- This study is interventional, prospective, comparative, superiority, multicentric, randomised by cluster, in closed cohort.
| Arm | Type | Receives |
|---|---|---|
| CONTROL GROUP | No intervention | –Control group (n = 16 nursing homes, 64 patients): Patients will be monitored as usual using the Venous International Normalised Ratio strategy. Practices will not be changed (i.e. prospective observation of real-life practices; according to recommendations, at least 1 Venous International Normalised Ratio per month will usually be performed) and patients will not receive any supplementary intervention specific to the trial. A reminder of good International Normalised Ratio practices will be provided to nurses and prescribers. |
| INTERVENTIONAL GROUP | Experimental | Device: Weekly monitoring using the capillary International Normalised Ratio strategyIntervention group (n = 16 nursing homes, 64 patients): Patients in the interventional group will be monitored using the capillary International Normalised Ratio strategy every week, and more often if the International Normalised Ratio is not in the therapeutic target. Venous International Normalised Ratio punctures will also be performed as described for the control group in order to calculate the Time in Therapeutic Range equivalently in both groups. Specific training in handling the device and the dose adjustment protocol will be provided to nurses and prescribers. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- The patient is participating in a Type 1 interventional study involving human beings (Jardé law).
- The patient is in an exclusion period determined by another study
- The patient is under safeguard of justice.
- It is not possible to give the patient (or his/her trusted-person/legal representative/tutor) informed information.
- The patient has a short life expectancy (< 1 month)
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 |
|---|---|---|
| Weekly monitoring using the capillary International Normalised Ratio strategyPatients in the interventional group will be monitored using the capillary International Normalised Ratio strategy every week, and more often if the International Normalised Ratio is not in the therapeutic target. Venous International Normalised Ratio punctures will also be performed as described for the control group in order to calculate the Time in Therapeutic Range equivalently in both groups. Specific training in handling the device and the dose adjustment protocol will be provided to nurses and prescribers. | Device | INTERVENTIONAL GROUP |
Primary outcome
Time in Therapeutic Range Using the Capillary International Normalized Range Weekly Monitoring Strategy
Time frame: Over 6 months
The CoaguChek INRange® device will be used. This small, portable monitoring medical device has already been used in several studies and can be used in hospital beds. After washing the patient's hands, the nurse will insert the strip test into the device, massaging the fingers and hand to activate blood circulation, and perform a capillary puncture using the lancet. An 8 μL drop of blood is required and must be deposited on the test strip less than 180 seconds after inserting the strip into the device and within 15 seconds after the start of blood drop formation. The International Normalized Ratio is displayed within one minute. When the nurse has the result, he/she will complete the VKA dose software (i.e. puncture number, strip number, current VKA type, current VKA dose, INRc value). The software will give the next puncture day and the correct VKA dose. If the INR > 4, there will be an alert and the nurse will have to contact the general practitioner for the rest of the procedure.
6 secondary outcomes
Venous Thromboembolic Events Occurring During the 6-month Monitoring Period.
Time frame: Day 0 to Month 6
Haemorrhagic Events Occurring During the 6-month Monitoring Period.
Time frame: Day 0 to Month 6
Time in Therapeutic Range Using International Normalized Range Weekly Monitoring Strategy in Patients ≤90.
Time frame: Day 0 to 6 months
Time in Therapeutic Range Using the International Normalized Range Weekly Monitoring Strategy in Patients >90.
Time frame: Day 0 to 6 months
Cost-consequences Study on the Weekly INRc Monitoring Strategy
Time frame: Day 0 to 6 months
Agreement Between Capillary and Veinous Measures
Time frame: Over 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
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, Dr. principal investigator
CHU de Nîmes (NUH) Place du Pr. Debré 30029 NIMES Cedex9
Karen ZERBIB, Dr. principal investigator
EHPAD "Korian Mas de Lauze", 17, Chemin du puits de Louiset 30900 NIMES
Patrick DUTILLEUL, Dr. principal investigator
EHPAD Résidence "l'Accueil", 75 Rue Louis Aragon, 30600 VAUVERT
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weekly monitoring using the capillary International Normalised Ratio strategy in people with Atrial Fibrillation and Deep Vein Thrombosis, run by Centre Hospitalier Universitaire de Nīmes at 33 sites 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 0 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: stopped early, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites 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?
Yes. Results are posted in the registry (first posted 3 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time in Therapeutic Range Using the Capillary International Normalized Range Weekly Monitoring Strategy (time frame: Over 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Mar 2026.