Impact of Renal Function Availability to Community Pharmacist for Dispensing Direct Oral Anticoagulant in Ambulatory Patients on Bleeding Occurrence (Hemorrag-IR)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Barbe Coralie, Dr
- Phone Number: +33 0326913665
- Email: coralie.barbe1@univ-reims.fr
Study Contact Backup
- Name: Badran Imane
- Phone Number: +33 0326918822
- Email: currs@univ-reims.fr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group 1 : pharmaceutical analysis of the prescription of Direct Oral Anticoagulant
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
|
pharmaceutical analysis
|
|
No Intervention: Group 2 : control group
No intervention (the community pharmacist takes no additional action to improve the patient's renal function)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
clinically significant bleeding at 3 months
Time Frame: Month 3
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
clinically significant bleeding at 6 months
Time Frame: Month 6
|
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 6
|
|
major bleeding at 3 months
Time Frame: Month 3
|
Bleeding requiring hospitalization or bleeding from a critical organ (intracerebral, intraocular, tamponade, …)
|
Month 3
|
|
major bleeding at 6 months
Time Frame: Month 6
|
Bleeding requiring hospitalization or bleeding from a critical organ (intracerebral, intraocular, tamponade, …)
|
Month 6
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023_RIPH_007_Hemorrag-Ir
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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