Clinical trial NCT06739603: Impact of Renal Function Availability to Community Pharmacist for Dispensing Direct Oral Anticoagulant in Ambulatory Patients on Bleeding Occurrence
Official title: Impact of Renal Function Availability to Community Pharmacist for Dispensing Direct Oral Anticoagulant in Ambulatory Patients on Bleeding Occurrence
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: AOD Prescription
Keywords: community pharmacist
AOD
renal function
bleeding
Lead sponsor: Université de Reims Champagne-Ardenne
Sponsor class: OTHER
First posted: 2024-12-18
Enrollment: 1920
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: The main objective is to study the benefit of access to the patient's renal function by the dispensing pharmacist when dispensing an AOD (first prescription or renewal) on the occurrence of clinically significant bleeding at 3 months.

Eligibility criteria: Inclusion Criteria:

* 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,
* agreeing to take part in the study (by signing the informed consent form).

Exclusion Criteria:

* prescribed another class of anticoagulant,
* minors,
* pregnant and breast-feeding women
* who do not understand French
* protected by law (guardianship, curatorship, safeguard of justice),
* refusing to take part in the study.

Primary outcomes:
measure: clinically significant bleeding at 3 months
timeFrame: Month 3
Secondary outcomes:
measure: clinically significant bleeding at 6 months
timeFrame: Month 6
measure: major bleeding at 3 months
timeFrame: Month 3
measure: major bleeding at 6 months
timeFrame: Month 6
Other outcomes:
Locations:
Study officials:
References: