Clinical trial NCT05561244: Weekly Monitoring Strategy of Capillary INR Versus Monthly Monitoring Strategy of Venous INR in Elderly Patients in a Nursing Home.
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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Atrial Fibrillation
Deep Vein Thrombosis
Stroke
Keywords: Atrial Fibrillation
Thrombosis
Stroke
Elderly
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2022-09-30
Enrollment: 45
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is interventional, prospective, comparative, superiority, multicentric, randomised by cluster, in closed cohort.
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: Inclusion Criteria: The population corresponds to nursing homes patients treated with Vitamin K Antagonists for more than six months, because INRc cannot be used while anticoagulation treatment is being introduced.

* The patient or his/her trusted-person/legal representative/tutor signed the consent form
* The patient is an adult and lives in a nursing home
* The patient has been on treatment with Vitamin K Antagonists for more than six months
* The patient's target INR range is 2,5 \[2-3\] or 3 \[2,5-3,5\]
* The patient is affiliated to a health insurance program

Exclusion Criteria:

* 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%

Primary outcomes:
measure: Interventional group : Time in Therapeutic Range using the capillary International Normalized Range weekly monitoring strategy
timeFrame: Day 0
measure: Interventional group : Time in Therapeutic Range using the capillary International Normalized Range weekly monitoring strategy
timeFrame: Month 6
measure: Control group : Time in Therapeutic Range using the venous International Normalized Range monthly monitoring strategy
timeFrame: Day 0
measure: Control group : Time in Therapeutic Range using the venous International Normalized Range monthly monitoring strategy
timeFrame: Month 6
Secondary outcomes:
measure: Interventional group: venous thromboembolic events occurring during the 6-month monitoring period.
timeFrame: Day 0 to Month 6
measure: Interventional group: haemorrhagic events occurring during the 6-month monitoring period.
timeFrame: Day 0 to Month 6
measure: Control group: venous thromboembolic events occurring with the monthly venous monitoring strategy.
timeFrame: Day 0 to Month 6
measure: Control group: haemorrhagic events occurring with the monthly venous monitoring strategy.
timeFrame: Day 0 to Month 6
measure: Interventional group : Time in Therapeutic Range using the capillary International Normalized Range weekly monitoring strategy in patients ≤90.
timeFrame: Day 0
measure: Interventional group : Time in Therapeutic Range using the capillary International Normalized Range weekly monitoring strategy in patients ≤90.
timeFrame: Month 6
measure: Interventional group : Time in Therapeutic Range using the capillary International Normalized Range weekly monitoring strategy in patients >90.
timeFrame: Day 0
measure: Interventional group : Time in Therapeutic Range using the capillary International Normalized Range weekly monitoring strategy in patients >90.
timeFrame: Month 6
measure: Control group: Time in Therapeutic Range using the monthly venous monitoring strategy in patients ≤90.
timeFrame: Day 0
measure: Control group: Time in Therapeutic Range using the monthly venous monitoring strategy in patients ≤90.
timeFrame: Month 6
measure: Control group: Time in Therapeutic Range using the monthly venous monitoring strategy in patients >90.
timeFrame: Day 0
measure: Control group: Time in Therapeutic Range using the monthly venous monitoring strategy in patients >90.
timeFrame: Month 6
measure: Interventional group : Cost-consequences study on the weekly INRc monitoring strategy
timeFrame: Month 6
measure: Interventional group : Budget impact analysis on the weekly INRc monitoring strategy
timeFrame: Year 3
measure: Control group : Cost-consequences study on the monthly venous monitoring strategy
timeFrame: Month 6
measure: Control group : Budget impact analysis on the monthly venous monitoring strategy
timeFrame: Year 3
Other outcomes:
Locations:
city: Aigues-mortes
country: France
facility: EHPAD " Coté Canal "
state: Gard
city: Alès
country: France
facility: EHPAD "Samdo Rochebelle"
state: Gard
city: Aramon
country: France
facility: EHPAD "Docteur Henry Granet"
state: Gard
city: Bernis
country: France
facility: EHPAD "Les Capitelles"
state: Gard
city: Cabrières
country: France
facility: EHPAD Résidence "Les Caprésianes"
state: Gard
city: Euzet
country: France
facility: EHPAD "Jean Lasserre"
state: Gard
city: Fons
country: France
facility: EHPAD "Les Jasses"
state: Gard
city: Garons
country: France
facility: EHPAD "Les 5 sens Garons"
state: Gard
city: Le Grau-du-Roi
country: France
facility: EHPAD Saint-Vincent de Paul
state: Gard
city: Meynes
country: France
facility: EHPAD "Sophia la Capitelle"
state: Gard
city: Montfrin
country: France
facility: EHPAD "Les oliviers"
state: Gard
city: Moussac
country: France
facility: EHPAD "Jacques Saurin"
state: Gard
city: Nimes
country: France
facility: Nîmes University Hospital, Place du Pr. Debré
state: Gard
city: Nîmes
country: France
facility: EHPAD "Ma Maison"
state: Gard
city: Nîmes
country: France
facility: EHPAD Serre-Cavalier Sites 1 and 2
state: Gard
city: Parignargues
country: France
facility: EHPAD ORPEA "Château Notre Dame"
state: Gard
city: Redessan
country: France
facility: EHPAD "Villa Rediciano"
state: Gard
city: Saint-martin-de-valgalgues
country: France
facility: EHPAD "Résidence les Magnans"
state: Gard
city: Uzes
country: France
facility: EHPAD "Les Jardins de l'Escalette"
state: Gard
city: Vauvert
country: France
facility: EHPAD Résidence "l'Accueil"
state: Gard
city: Lunel
country: France
facility: EHPAD Korian "Les Meunières"
state: Herault
city: Montpellier
country: France
facility: EHPAD Malbosc
state: Herault
city: St Bauzille de Putois
country: France
facility: SCM Médicale St Bauzille de Putois
state: Herault
city: Ganges
country: France
facility: EHPAD "Les Dominicaines"
state: Hérault
city: Montpellier
country: France
facility: Maison de Retraite Protestante
state: Hérault
city: Montpellier
country: France
facility: EHPAD "Les Monts d'Aurelle"
state: Hérault
city: St Gely Du Fesc
country: France
facility: EHPAD "La BELLE Viste"
state: Hérault
city: Langogne
country: France
facility: EHPAD du centre hospitalier de Langogne
state: Lozere
city: Laurens
country: France
facility: EHPAD La Murelle
city: Montpellier
country: France
facility: Centre Bellevue-CHU Montpellier
city: Nîmes
country: France
facility: EHPAD "Korian Mas de Lauze"
city: Vergeze
country: France
facility: EHPAD La Pinède
city: Villelongue Dels Monts
country: France
facility: EHPAD Léon Bourgeois
Study officials:
affiliation: CHU de Nîmes (NUH) Place du Pr. Debré 30029 NIMES Cedex9
name: Chloé SIKIRDJI, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: EHPAD "Korian Mas de Lauze", 17, Chemin du puits de Louiset 30900 NIMES
name: Karen ZERBIB, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: EHPAD Résidence "l'Accueil", 75 Rue Louis Aragon, 30600 VAUVERT
name: Patrick DUTILLEUL, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: EHPAD "Les Jardins de l'Escalette",1 Avenue Marechal Foch 30700 UZES
name: Alain BROUSSE, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: EHPAD Malbosc, 345 Avenue de Fes 34090 MONTPELLIER
name: Elodie MILLION, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: EHPAD "Sophia la Capitelle", 57 Rue Henri Pitot 30840 MEYNES
name: Philippe SERAYET, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: EHPAD "Docteur Henry Granet", 23 Chemin de la grave 30390 ARAMON +EHPAD "Les oliviers", 420 Chem. de Ceserac 30490 MONTFRIN
name: Thierry CORNILLE, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: EHPAD "les Caprésianes",111 r. Alphonse Daudet 30210 CABRIERES, "Villa Rediciano", 6 r. du 19 Mars 1962, 30129 REDESSAN
name: Gilles SEYLER, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: EHPAD "Les Jasses", 155 Rue des Clapas 30730 FONS
name: Gil MEYRAND, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: EHPAD "Jacques Saurin", Avenue des Loisirs 30190 MOUSSAC
name: Philippe VERNEDE, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: EHPAD "Jean Lasserre", Chem. des Camisards 30360 EUZET
name: Katia BRUNEL, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: EHPAD "Les Capitelles", Impasse de la Thebaide 30620 BERNIS
name: Georges ALVADO, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: EHPAD Serre-Cavalier - Sites 1 & 2, Rue Pitot Prolongée 30000 Nîmes
name: Christine DE TADDEO, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: EHPAD ORPEA "Château notre dame", Pl. du Château 30730 PARIGNARGUES
name: Marie-Hélène GRAS-JAEN, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: EHPAD Samdo Rochebelle, 17 Rue des Châtaigniers 30100 ALES
name: Marc BORGHERO, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: EHPAD "Les 5 sens Garons", Carieire dis Amourous 30128 GARONS
name: Anne-Laure VITEAU, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: EHPAD Korian "Les Meunières" Place Denfert Rochereau 34400 LUNEL
name: Abderrahmane ALOUI, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: EHPAD du Centre hospitalier de Langogne, Clos de la Tuilerie 48300 LANGOGNE
name: Pierre MERLE, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: EHPAD Saint-Vincent de Paul,16 Rue de l'Égalité 30240 LE GRAU-DU-ROI
name: Marc DUPUIS, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: EHPAD "Coté Canal", 116 Rue Jacques Cœur 30220 AIGUES-MORTES
name: Julie LANO, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: EHPAD "La belle viste", 149 Rue du parc BP 2 34980 ST GELY DU FESC
name: Florence CHAPOUTOUT, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: EHPAD "Les monts d'Aurelle",Parc Euromedecine 1632 Rue St Priest 34097 MONTPELLIER CEDEX 5
name: Nicole GARCIA, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Maison de Retraite Protestante, 2252 Rte de Mende 34090 MONTPELLIER
name: Robert LE STUM, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: EHPAD "les Dominicaines",2 Rue du Thirondel 34190 GANGES
name: Marie-Aude BONNEL, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: EHPAD "Résidence les Magnans", 85 Rue du Dix Neuf Mars 1962, 30520 SAINT-MARTIN-DE-VALGALGUES
name: Adrien ROMARY, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: 68 rue du charron 30310 VERGEZE
name: Mélanie BADIN, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: SCM Médicale St Bauzille de Putois 1193 avenue du chemin neuf 34190 ST BAUZILLE DE PUTOIS
name: Murielle GLONDU-LASSIS, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: 2 rue Ibn Sinaï Dit Avicenne 66330 Cabestany
name: Hermine SAGUY, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: 392 Boulevard Pedro de Luna 34070 MONTPELLIER
name: Anne-Sophie ODOUL, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: EHPAD Léon Bourgeois 1 Place du Puig Tarrous 66740 VILLELONGUE DELS MONTS
name: Victor LIVIOT, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: EHPAD La Pinède 110 chemin des cades 30310 Vergeze
name: Philippe Roure, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Bellevue-CHU Montpellier 1 Pl. Jean Baumel 34090 Montpellier
name: Franck Raschilas, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: EHPAD La Murelle Avenue de la Gare 34480 - LAURENS
name: Chloé Loeffler, Dr.
role: PRINCIPAL_INVESTIGATOR
References: