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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06739603
Acronym
Hemorrag-IR
Enrollment
1920
Registered
2024-12-18
Start date
2025-06-01
Completion date
2027-12-01
Last updated
2024-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AOD Prescription

Keywords

community pharmacist, AOD, renal function, bleeding

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.

Interventions

OTHERpharmaceutical analysis

pharmaceutical analysis

Sponsors

Université de Reims Champagne-Ardenne
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
clinically significant bleeding at 3 monthsMonth 3Bleeding 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)

Secondary

MeasureTime frameDescription
clinically significant bleeding at 6 monthsMonth 6Bleeding 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)
major bleeding at 3 monthsMonth 3Bleeding requiring hospitalization or bleeding from a critical organ (intracerebral, intraocular, tamponade, …)
major bleeding at 6 monthsMonth 6Bleeding requiring hospitalization or bleeding from a critical organ (intracerebral, intraocular, tamponade, …)

Contacts

Primary ContactBadran Imane
currs@univ-reims.fr0326918822
Backup ContactBarbe Coralie, Dr
coralie.barbe1@univ-reims.fr0326913665

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 7, 2026