CClinicalTrials.gg
CompletedNCT06100380Updated May 30, 2024

Elaboration of a Prioritization Score for Pharmaceutical Interviews in Patients Treated With Oral Anticoagulants

An observational study in Thromboembolic Event, sponsored by CHU de Reims. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-30.

Sponsored by CHU de Reims · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
197
Ages
18 Years and older
Sex
All
01

Study summary

Oral anticoagulants have a prominent place in the strategy of prevention and treatment of thromboembolic diseases, especially in patients with atrial fibrillation. However, a study conducted by the National Fund for Health Insurance (Caisse primaire d'Assurance maladie, CPAM) in 2017 among nearly 35,000 patients with non-valvular atrial fibrillation showed that one in five patients stopped their oral anticoagulant without medical advice for at least 60 days during the first year of treatment.

In our establishment, patients hospitalized in the Cardiology departments and treated with oral anticoagulants benefit from pharmaceutical interviews on their treatment before they return at home. This activity, which exists since November 2014, is based on a team consisting on a pharmacy student, supervised by a pharmacist trained in therapeutic education.

In order to secure the management of patients treated by oral anticoagulants and to answer the requirements of Certification, the investigators wish to extend the pharmaceutical interviews to all of hospital's healthcare services. However, the large number of patients concerned, the shorter hospital stays and the difficulties to organize collective sessions in front of the diversity of treatments and diseases are parameters to be taken into account in the development of this activity. The provision of a targeting tool for patients with high risk of thromboembolism and / or hemorrhage is a prerequisite for organizing this institutional approach to support patients on anticoagulants.

In this context, the investigators want to establish a prioritization score to identify patients on oral anticoagulants with a higher drug risk.

Read the detailed description

Oral anticoagulants are represented by two classes: vitamin K antagonists (VKA) and non-VKA oral anticoagulants (DOAC). They have a prominent place in the strategy of prevention and treatment of thromboembolic diseases, especially in patients with atrial fibrillation. Their prescription continues to increase in France.

However, a study conducted by the National Fund for Health Insurance (Caisse primaire d'Assurance maladie, CPAM) in 2017 among nearly 35,000 patients with non-valvular atrial fibrillation showed that one in five patients stopped their oral anticoagulant without medical advice for at least 60 days during the first year of treatment.

In our establishment, patients hospitalized in the Cardiology departments and treated with oral anticoagulants benefit from pharmaceutical interviews on their treatment before they return at home. This activity, which exists since November 2014, is based on a team consisting on a pharmacy student, supervised by a pharmacist trained in therapeutic education.

In order to secure the management of patients treated by oral anticoagulants and to answer the requirements of Certification, he investigators wish to extend the pharmaceutical interviews to all of hospital's healthcare services. However, the large number of patients concerned, the shorter hospital stays and the difficulties to organize collective sessions in front of the diversity of treatments and diseases are parameters to be taken into account in the development of this activity. The provision of a targeting tool for patients with high risk of thromboembolism and / or hemorrhage is a prerequisite for organizing this institutional approach to support patients on anticoagulants.

In this context, the investigators want to establish a prioritization score to identify patients on oral anticoagulants with a higher drug risk. Case-control study was performed at University hospital of Reims.

02

Conditions studied

  • Thromboembolic Event

Browse trials for

03

In context

Thromboembolism

818 studies on the registry are indexed under Thromboembolism; 97 are open to participants now.

This study's enrollment of 197 is below the median of 500 across 344 observational studies indexed under Thromboembolism.

Browse Thromboembolism studies →

Lead sponsor

CHU de Reims is the lead sponsor of 267 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients will be selected during their hospitalization at University hospital of Reims if they are treated with an oral anticoagulant.

Inclusion criteria

  • For the case-subjects:
  • Patient hospitalized at the Reims university hospital
  • Patient treated with an oral anticoagulant (vitamin K antagonist: VKA or non-VKA oral anticoagulant: DOAC) since at least one month
  • Patient with a serious hemorrhage or a thromboembolic event.
  • For the control-subjects:
  • Patient hospitalized at the Reims university hospital
  • Patient treated with an oral anticoagulant (vitamin K antagonist: VKA or non-VKA oral anticoagulant: DOAC) since at least one month
  • Without a serious hemorrhage or a thromboembolic event.

Exclusion criteria

Exclusion Criteria:

  • Patient physically or mentally not able to express non-opposition or opposition to the study;
  • Patient protected by law;
  • Patient physically or mentally not able to answer the surveys;
  • Patient hospitalized in the month preceding the inclusion;
  • Patient discharged from hospital before having answering the surveys.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
197 participants (actual)
Patient registry
No

Groups and cohorts

  • patients with Thromboembolic event and Hemorrhage group

    patients who present a hemorrhage or a thromboembolic event

    Other: Survey

  • patients without Thromboembolic event and Hemorrhage

    patients who don't present a hemorrhage or a thromboembolic event

    Other: Survey

Interventions

  • OtherSurvey

    Questionnaire

06

What researchers measure

Primary outcomes

  1. Number of thromboembolic event in patients treated with an oral anticoagulant

    Time frame: 1 day

07

Study locations

1 site
  • Chu Reims
    Reims, 51092, France
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 30, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06100380
Lead sponsor
CHU de Reims
Responsible party
Sponsor
First posted
Oct 25, 2023
Start date
Sep 20, 2020
Primary completion
Nov 17, 2021
Completion
Oct 1, 2023
Last update
May 30, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion