Clinical Trial

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

Study acronym: Hemorrag-IR
Not Yet Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated December 18, 2024 (before its estimated June 1, 2025 completion). Its status may not reflect the trial's current state.
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.
Trial Details
NCT Number NCT06739603
Lead Sponsor Université de Reims Champagne-Ardenne
Conditions AOD Prescription
Enrollment 1,920 participants
Start Date 2025-06-01
Primary Completion 2025-06-01 (estimated)
Study Completion 2027-12-01 (estimated)
Updated on ClinicalTrials.gov 2024-12-18