2022-A00516-37

About this trial

Last updated a year ago

Study ID

2022-A00516-37

Status

Recruiting

Type

Interventional

Phase

N/A

Placebo

Accepting

60+ Years

All

Not accepting

Healthy Volunteers

Trial Timing

Started 3 years ago

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.

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%