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NCT Number: NCT06739603

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

pharmaceutical analysis

Other

pharmaceutical analysis

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. major bleeding at 3 months

    Time frame: Month 3

    Bleeding requiring hospitalization or bleeding from a critical organ (intracerebral, intraocular, tamponade, …)

  3. major bleeding at 6 months

    Time frame: Month 6

    Bleeding requiring hospitalization or bleeding from a critical organ (intracerebral, intraocular, tamponade, …)

Study contacts

Contact information is provided by the study sponsor or research team.

Badran Imane

CONTACT

[email protected]

0326918822 ext. +33

Barbe Coralie, Dr

CONTACT

[email protected]

0326913665 ext. +33

Sponsors and collaborators

Lead sponsor

Université de Reims Champagne-Ardenne

Other

Registry information

Acronym: Hemorrag-IR

Important dates

Study start
2025
Primary completion
2025
Study completion
2027
First posted
Dec 18, 2024
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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