Atrial FibrillationREINACONCT02964546
Glomerular Filtration Rate-Estimating Equations During Use of Direct Oral Anticoagulants in Elderly Patients
An observational study of Atrial Fibrillation and Elderly Patients, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Atrial fibrillation in the elderly is a complex condition due to the high number of frequently associated comorbidities such kidney disease. Direct oral anticoagulants (dabigatran, rivaroxaban and apixaban) are indicated for preventing thromboembolic events but renal function should be closely monitored for this age… Read more about this study
- Who is it for?
- Ages 65 to 99 years
- Conditions the study is for
- Atrial Fibrillation, Elderly Patients, Chronic Kidney Disease
- What is being tested?
- Blood sample
- How many people
- 116 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jun 2015to 7 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 65 to 99 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients with non-valvular atrial fibrillation treated with dabigatran, rivaroxaban or apixaban
Who may be able to join
- Patients with non-valvular atrial fibrillation -treated with dabigatran, rivaroxaban or apixaban - patients affiliated to national social health system -patients who agreed to ethical concerns of the study
Who cannot join
- Patients with consultation or hospitalization that made impossible a veinous punction at the steady state residual concentration time -Patients under guardianship or trusteeship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of the Choice of Glomerular Filtration Rate-Estimating Equations on Plasmatic Concentrations of Direct Oral Anticoagulants in Elderly Patients With Atrial Fibrillation
Atrial fibrillation in the elderly is a complex condition due to the high number of frequently associated comorbidities such kidney disease. Direct oral anticoagulants (dabigatran, rivaroxaban and apixaban) are indicated for preventing thromboembolic events but renal function should be closely monitored for this age group when these drugs are used. Dosing recommendations for prevention of stroke are based on renal clearance of creatinine (ClCr) estimated using the Cockcroft-Gault formula. It is well known that ClCr estimates predict a steeper decline with advancing age than Glomerular Filtration Rate (GFR) estimates. This raises the possibility that substitution of commonly reported GFR for estimated CrCl could result in different plasmatic concentrations of oral direct anticoagulants. The aim of this study was to compare estimates of ClCr and GFR and determine the impact on the plasmatic concentration of these drugs in elderly patients with non-valvular atrial fibrillation.
- Being tested
- Blood sample
- Keywords
- direct oral anticoagulants, atrial fibrillation, renal function, ckd-epi, plasmatic concentration
- Medical subject headings
- Atrial Fibrillation, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
2 additional tubes of blood samples are collected during a blood sample realized for the patient's care
| Study group | Role | What they receive |
|---|---|---|
| Blood sample | Not described Receives: Other: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
renal function estimated by different glomerular filtration rate equations and by clearance of creatinine formula
Measured: At the inclusion
Secondary outcomes (4)
plasmatic activity of direct oral anticoagulant at steady state residual time (anti-Xa or anti-IIa)
Measured: At the inclusion
plasmatic concentration of direct oral anticoagulant at steady state residual time
Measured: At the inclusion
Number of haemorrhagic or thrombotic adverse events (serious or not) affecting patients
Reported by a trained physician after a phone interview with the patient coupled with medication adherence assessment using 6-item Moriksy scale. An internal questionnaire will be used to collect data.
Measured: At 1 month
Number of haemorrhagic or thrombotic adverse events (serious or not) and unexpected events affecting patients
Reported by a trained physician after a phone interview with the general practitioner and the patient coupled with medication adherence assessment using 6-item Moriksy scale. An internal questionnaire will be used to collect data.
Measured: At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2016 (estimated)
- Study start8 Jun 2015
- Primary completion20 Nov 2017
- Study completion7 Dec 2018
Why it stopped: recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02964546
- Sponsor's protocol ID
- 9539
- Other IDs
- 2015-A00453-46
- Acronym
- REINACO
- Status last verified
- Oct 2021
- First submitted
- 9 Sep 2016
- Last updated
- 20 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Choice of Glomerular Filtration Rate-Estimating Equations on Plasmatic Concentrations of Direct Oral Anticoagulants in Elderly Patients With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT02964546
- Acronym / sponsor ID
- REINACO / 9539
- Keywords
- direct oral anticoagulants, atrial fibrillation, renal function, ckd-epi, plasmatic concentration
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: recruitment difficulties
- Enrolment
- 116 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 8 Jun 2015 (actual)
- Primary completion
- 20 Nov 2017 (actual)
- Study completion
- 7 Dec 2018 (actual)
- First posted
- 16 Nov 2016 (estimated)
- 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.
Atrial fibrillation in the elderly is a complex condition due to the high number of frequently associated comorbidities such kidney disease. Direct oral anticoagulants (dabigatran, rivaroxaban and apixaban) are indicated for preventing thromboembolic events but renal function should be closely monitored for this age group when these drugs are used. Dosing recommendations for prevention of stroke are based on renal clearance of creatinine (ClCr) estimated using the Cockcroft-Gault formula. It is well known that ClCr estimates predict a steeper decline with advancing age than Glomerular Filtration Rate (GFR) estimates. This raises the possibility that substitution of commonly reported GFR for estimated CrCl could result in different plasmatic concentrations of oral direct anticoagulants. The aim of this study was to compare estimates of ClCr and GFR and determine the impact on the plasmatic concentration of these drugs in elderly patients with non-valvular atrial fibrillation.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood sample | – | Other: Blood sample |
Who may qualify
- Ages
- 65 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients with non-valvular atrial fibrillation treated with dabigatran, rivaroxaban or apixaban
Key inclusion criteria (1 listed)
- Patients with non-valvular atrial fibrillation -treated with dabigatran, rivaroxaban or apixaban - patients affiliated to national social health system -patients who agreed to ethical concerns of the study
Key exclusion criteria (1 listed)
- Patients with consultation or hospitalization that made impossible a veinous punction at the steady state residual concentration time -Patients under guardianship or trusteeship
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 |
|---|---|---|
| Blood sample2 additional tubes of blood samples are collected during a blood sample realized for the patient's care | Other | Blood sample |
Primary outcome
renal function estimated by different glomerular filtration rate equations and by clearance of creatinine formula
Time frame: At the inclusion
4 secondary outcomes
plasmatic activity of direct oral anticoagulant at steady state residual time (anti-Xa or anti-IIa)
Time frame: At the inclusion
plasmatic concentration of direct oral anticoagulant at steady state residual time
Time frame: At the inclusion
Number of haemorrhagic or thrombotic adverse events (serious or not) affecting patients
Time frame: At 1 month
Number of haemorrhagic or thrombotic adverse events (serious or not) and unexpected events affecting patients
Time frame: At 6 months
Results and safety
The study was stopped early (reason given: recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2021.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Elderly Patients, run by University Hospital, Montpellier at 1 site in France.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 20 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was stopped early (reason given: recruitment difficulties). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
renal function estimated by different glomerular filtration rate equations and by clearance of creatinine formula (time frame: At the inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Oct 2021.