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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое pharmaceutical analysis
  pharmaceutical analysis

Первичные конечные точки

• clinically significant bleeding at 3 months [Срок оценки: Month 3]

Вторичные конечные точки (3)

• clinically significant bleeding at 6 months [Срок оценки: Month 6]
• major bleeding at 3 months [Срок оценки: Month 3]
• major bleeding at 6 months [Срок оценки: Month 6]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Badran I, Clarenne J, Mongaret C, Ohl-Hurtaud A, Barbe C, Slimano F. Access to renal function information to improve pharmaceutical care in direct oral anticoagulant users: a cluster randomized trial protocol. BMC Prim Care. 2026 Jun 6. doi: 10.1186/s12875-026-03413-3. Online ahead of print. PMID 42249299

Идентификаторы

NCT: NCT06739603 · 2023_RIPH_007_Hemorrag-Ir

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗