Clinical trial NCT02964546: Glomerular Filtration Rate-Estimating Equations During Use of Direct Oral Anticoagulants in Elderly Patients
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Atrial Fibrillation
Elderly Patients
Chronic Kidney Disease
Keywords: direct oral anticoagulants
atrial fibrillation
renal function
ckd-epi
plasmatic concentration
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2016-11-16
Enrollment: 116
Sex: ALL
Minimum age (years): 65
Maximum age (years): 99
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with non-valvular atrial fibrillation treated with dabigatran, rivaroxaban or apixaban

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

Patients with consultation or hospitalization that made impossible a veinous punction at the steady state residual concentration time -Patients under guardianship or trusteeship

Primary outcomes:
measure: renal function estimated by different glomerular filtration rate equations and by clearance of creatinine formula
timeFrame: At the inclusion
Secondary outcomes:
measure: plasmatic activity of direct oral anticoagulant at steady state residual time (anti-Xa or anti-IIa)
timeFrame: At the inclusion
measure: plasmatic concentration of direct oral anticoagulant at steady state residual time
timeFrame: At the inclusion
measure: Number of haemorrhagic or thrombotic adverse events (serious or not) affecting patients
timeFrame: At 1 month
measure: Number of haemorrhagic or thrombotic adverse events (serious or not) and unexpected events affecting patients
timeFrame: At 6 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University Hospital
Study officials:
References: