Glomerular Filtration Rate-Estimating Equations During Use of Direct Oral Anticoagulants in Elderly Patients

Terminated

• Conditions: Chronic Kidney Disease; Elderly Patients; Atrial Fibrillation
• Interventions: Other: Blood sample

• Registration Number: NCT02964546
• Lead Sponsor: University Hospital, Montpellier

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-08
• Study First Submitted: 2016-09-09
• Study First Submitted QC: 2016-11-10
• Study First Posted: 2016-11-16
• Primary Completion: 2017-11-20
• Study Completion: 2018-12-07
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-12
• Last Update Posted: 2021-10-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 116

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Blood sample	Blood sample	-

Primary Outcome Measures

Name	Time	Method
renal function estimated by different glomerular filtration rate equations and by clearance of creatinine formula	At the inclusion

Secondary Outcome Measures

Name	Time	Method
Number of haemorrhagic or thrombotic adverse events (serious or not) affecting patients	At 1 month	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.
plasmatic activity of direct oral anticoagulant at steady state residual time (anti-Xa or anti-IIa)	At the inclusion
plasmatic concentration of direct oral anticoagulant at steady state residual time	At the inclusion
Number of haemorrhagic or thrombotic adverse events (serious or not) and unexpected events affecting patients	At 6 months	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.

Trial Locations

Locations (1)

University Hospital; 🇫🇷 Montpellier, France