Ignite Creation Date:
2024-05-06 @ 6:09 PM
Last Modification Date:
2024-10-26 @ 2:42 PM
Study NCT ID:
NCT05561244
Status:
RECRUITING
Last Update Posted:
2024-02-07
First Post:
2022-09-27
Brief Title:
Weekly Monitoring Strategy of Capillary INR Versus Monthly Monitoring Strategy of Venous INR in Elderly Patients in a Nursing Home
Sponsor:
Centre Hospitalier Universitaire de Nīmes
Organization:
Centre Hospitalier Universitaire de Nīmes
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INR-CAP
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 25 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 benefitrisk 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 riskbenefit ratio is 70 In other countries it has been shown that the TTR is higher 61 in Canada 644 in Spain 689 in Italy and 762 in Sweden Moreover TTR determines the benefitrisk 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 06 per 100 patient-years for gastrointestinal bleeding it is 10 per 100 patient-years and the risk of other serious bleeding is 14 per 100 patient-years This risk of bleeding is usually assessed using the HAS-BLED score The risk of hemorrhage is 42 per year in patients over 75 versus 17 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
One parameter used to evaluate the benefitrisk 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 riskbenefit ratio is 70 In other countries it has been shown that the TTR is higher 61 in Canada 644 in Spain 689 in Italy and 762 in Sweden Moreover TTR determines the benefitrisk 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 06 per 100 patient-years for gastrointestinal bleeding it is 10 per 100 patient-years and the risk of other serious bleeding is 14 per 100 patient-years This risk of bleeding is usually assessed using the HAS-BLED score The risk of hemorrhage is 42 per year in patients over 75 versus 17 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None