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

NCT06739603 | Not Yet Recruiting

• 1 other identifier: 2023_RIPH_007_Hemorrag-Ir
• Study Type: interventional
• Target: 1,920
• Locations: 0 countries
• Sites: N/A

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.

Conditions

AOD Prescription

Keywords

community pharmacist; AOD; renal function; bleeding

Outcome Measures

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)

  Month 3

Secondary Outcomes (3)

• clinically significant bleeding at 6 months

  Month 6

• major bleeding at 3 months

  Month 3

• major bleeding at 6 months

  Month 6

Study Arms (2)

Group 1 : pharmaceutical analysis of the prescription of Direct Oral Anticoagulant

EXPERIMENTAL

community pharmacist makes every effort to obtain the patient's renal function in order to carry out a pharmaceutical analysis of the prescription of Direct Oral Anticoagulant

Other: pharmaceutical analysis

Group 2 : control group

NO INTERVENTION

No intervention (the community pharmacist takes no additional action to improve the patient's renal function)

Interventions

pharmaceutical analysis OTHER

pharmaceutical analysis

Group 1 : pharmaceutical analysis of the prescription of Direct Oral Anticoagulant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Université de Reims Champagne-Ardenne: lead

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Badran Imane

CONTACT

0326918822; currs@univ-reims.fr

Barbe Coralie, Dr

CONTACT

0326913665; coralie.barbe1@univ-reims.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: December 18, 2024
• Study Start: June 1, 2025
• Primary Completion: June 1, 2025
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 18, 2024

Record last verified: 2024-12