Impact of Renal Function Availability to Community Pharmacist for Dispensing Direct Oral Anticoagulant in Ambulatory Patients on Bleeding Occurrence

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversité de Reims Champagne-Ardenne

About this trial

The use of direct oral anticoagulants (AODs) in the prevention and treatment of thromboembolic diseases is increasing, with a favorable benefit/risk balance and improved quality of life for patients. However, anticoagulants are still associated with a risk of bleeding, making them one of the drugs most likely to cause adverse events and serious adverse events. Certain clinical situations are particularly at risk of bleeding with AODs, notably renal failure (even moderate) and age over 75, due to the predominant renal elimination of these drugs. Prescription and monitoring of AOD treatment are conditional on monitoring of renal function and, if necessary, appropriate dosage adjustments.

Community pharmacists dispense AODs on a daily basis, following pharmaceutical analysis. Good dispensing practice recommends that community pharmacists have access to biological data. Studies have suggested that access to renal function enables community pharmacists to carry out targeted and appropriate interventions. This expected clinical pharmaceutical expertise is conditional on access to this biological data. In practice, community pharmacists are not systematically aware of this renal function, and are therefore unable to carry out a pharmaceutical intervention if necessary. Initiatives implemented by general practitioners seem to be emerging (systematic addition of the renal to the medical prescription), but these practices do not currently guarantee systematic access to this data. A strong argument in favor of systematically making the renal available to community pharmacists would be to demonstrate that access to this biological data reduces the occurrence of adverse events linked to AODs.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

with a prescription for an AOD (first prescription or renewal),

whatever the indication of the AOD treatment,

coming to one of the study's partner pharmacies for dispensing,

adults,

Disqualifiers

prescribed another class of anticoagulant,

minors,

pregnant and breast-feeding women

who do not understand French

Trial design

Design model

Parallel

Treatments tested in this trial

  • pharmaceutical analysis

    Other intervention

    pharmaceutical analysis

Treatment groups

1,920 Participants
are divided into 2 treatment groups
Group A: Group 1 : pharmaceutical analysis of the prescription of Direct Oral AnticoagulantExperimental treatment 1 intervention
Group B: Group 2 : control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

clinically significant bleeding at 3 months

Bleeding requiring unscheduled consultation with general practitioner or specialist, regardless of the type of treatment required (therapeutic abstention, medical management with or without hospitalization, surgical management) and regardless of the type of AOD's treatment management (no change, change or discontinuation)

Time frame
Month 3

Secondary outcomes

1

clinically significant bleeding at 6 months

Bleeding requiring unscheduled consultation with general practitioner or specialist, regardless of the type of treatment required (therapeutic abstention, medical management with or without hospitalization, surgical management) and regardless of the type of AOD's treatment management (no change, change or discontinuation)

Time frame
Month 6
2

major bleeding at 3 months

Bleeding requiring hospitalization or bleeding from a critical organ (intracerebral, intraocular, tamponade, …)

Time frame
Month 3
3

major bleeding at 6 months

Bleeding requiring hospitalization or bleeding from a critical organ (intracerebral, intraocular, tamponade, …)

Time frame
Month 6

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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