Impact of Renal Function Availability to Community Pharmacist for Dispensing Direct Oral Anticoagulant in Ambulatory Patients on Bleeding Occurrence
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,920
- 主要终点
- clinically significant bleeding at 3 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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,
- •agreeing to take part in the study (by signing the informed consent form).
排除标准
- •prescribed another class of anticoagulant,
- •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.
研究组 & 干预措施
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
干预措施: pharmaceutical analysis (Other)
Group 2 : control group
No intervention (the community pharmacist takes no additional action to improve the patient's renal function)
结局指标
主要结局
clinically significant bleeding at 3 months
时间窗: 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)
次要结局
- clinically significant bleeding at 6 months(Month 6)
- major bleeding at 3 months(Month 3)
- major bleeding at 6 months(Month 6)
