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

NCT ID: NCT06739603

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

1920 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2027-12-01

Brief Summary

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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

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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.

Conditions

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AOD Prescription

Keywords

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community pharmacist AOD renal function bleeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

pharmaceutical analysis

Intervention Type OTHER

pharmaceutical analysis

Group 2 : control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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pharmaceutical analysis

pharmaceutical analysis

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Université de Reims Champagne-Ardenne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Badran Imane

Role: CONTACT

Phone: 0326918822

Email: [email protected]

Barbe Coralie, Dr

Role: CONTACT

Phone: 0326913665

Email: [email protected]

Other Identifiers

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2023_RIPH_007_Hemorrag-Ir

Identifier Type: -

Identifier Source: org_study_id