pharmaceutical analysis
Otherpharmaceutical analysis
NCT Number: NCT06739603
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
pharmaceutical analysis
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)
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)
Time frame: Month 3
Bleeding requiring hospitalization or bleeding from a critical organ (intracerebral, intraocular, tamponade, …)
Time frame: Month 6
Bleeding requiring hospitalization or bleeding from a critical organ (intracerebral, intraocular, tamponade, …)
Contact information is provided by the study sponsor or research team.
Université de Reims Champagne-Ardenne
Other
Acronym: Hemorrag-IR
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