AOD PrescriptionHemorrag-IRNCT06739603
Impact of Renal Function Availability to Community Pharmacist for Dispensing Direct Oral Anticoagulant in Ambulatory Patients on Bleeding Occurrence
A study testing pharmaceutical analysis in people with AOD Prescription, run by Université de Reims Champagne-Ardenne.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AOD Prescription
- What is being tested?
- pharmaceutical analysis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,920 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
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
- AOD Prescription
- Being tested
- pharmaceutical analysis
- Keywords
- community pharmacist, AOD, renal function, bleeding
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pharmaceutical analysisOther
pharmaceutical analysis
| Study group | Role | What they receive |
|---|---|---|
| Group 1 : pharmaceutical analysis of the prescription of Direct Oral Anticoagulant | Experimental | 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 Receives: Other: pharmaceutical analysis |
| Group 2 : control group | No intervention | No intervention (the community pharmacist takes no additional action to improve the patient's renal function) |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinically significant bleeding at 3 months
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)
Measured: Month 3
Secondary outcomes (3)
clinically significant bleeding at 6 months
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)
Measured: Month 6
major bleeding at 3 months
Bleeding requiring hospitalization or bleeding from a critical organ (intracerebral, intraocular, tamponade, …)
Measured: Month 3
major bleeding at 6 months
Bleeding requiring hospitalization or bleeding from a critical organ (intracerebral, intraocular, tamponade, …)
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start1 Jun 2025 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AOD PrescriptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,920 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Reims Champagne-Ardenne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06739603
- Sponsor's protocol ID
- 2023_RIPH_007_Hemorrag-Ir
- Acronym
- Hemorrag-IR
- Status last verified
- Dec 2024
- First submitted
- 12 Dec 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 42249299
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Renal Function Availability to Community Pharmacist for Dispensing Direct Oral Anticoagulant in Ambulatory Patients on Bleeding Occurrence
- ClinicalTrials.gov ID
- NCT06739603
- Acronym / sponsor ID
- Hemorrag-IR / 2023_RIPH_007_Hemorrag-Ir
- Conditions
- AOD Prescription
- Keywords
- community pharmacist, AOD, renal function, bleeding
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,920 participants (estimated)
- Lead sponsor
- Université de Reims Champagne-ArdenneUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 18 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 : pharmaceutical analysis of the prescription of Direct Oral Anticoagulant | Experimental | Other: pharmaceutical analysiscommunity 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 2 : control group | No intervention | –No intervention (the community pharmacist takes no additional action to improve the patient's renal function) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (6 listed)
- prescribed another class of anticoagulant,
- minors,
- pregnant and breast-feeding women
- who do not understand French
- protected by law (guardianship, curatorship, safeguard of justice),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pharmaceutical analysispharmaceutical analysis | Other | Group 1 : pharmaceutical analysis of the prescription of Direct Oral Anticoagulant |
Primary outcome
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)
3 secondary outcomes
clinically significant bleeding at 6 months
Time frame: Month 6
major bleeding at 3 months
Time frame: Month 3
major bleeding at 6 months
Time frame: Month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Derived from this study: PubMed 42249299Badran 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing pharmaceutical analysis in people with AOD Prescription, run by Université de Reims Champagne-Ardenne.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Badran Imane (0326918822 ext. +33, currs@univ-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinically significant bleeding at 3 months (time frame: Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06739603, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.