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

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.

Study Overview

• Status: Terminated
• Conditions: Atrial Fibrillation; Chronic Kidney Disease; Elderly Patients
• Intervention / Treatment: Other: Blood sample

• Study Type: Observational
• Enrollment (Actual): 116

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 99 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with non-valvular atrial fibrillation treated with dabigatran, rivaroxaban or apixaban

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Blood sample	Other: Blood sample; 2 additional tubes of blood samples are collected during a blood sample realized for the patient's care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
renal function estimated by different glomerular filtration rate equations and by clearance of creatinine formula	At the inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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) 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.	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.	At 6 months

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2015
• Primary Completion (Actual): November 20, 2017
• Study Completion (Actual): December 7, 2018

Study Registration Dates

• First Submitted: September 9, 2016
• First Submitted That Met QC Criteria: November 10, 2016
• First Posted (Estimate): November 16, 2016

Study Record Updates

• Last Update Posted (Actual): October 20, 2021
• Last Update Submitted That Met QC Criteria: October 12, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: atrial fibrillation; renal function; direct oral anticoagulants; plasmatic concentration; ckd-epi
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Urologic Diseases; Renal Insufficiency; Arrhythmias, Cardiac; Kidney Diseases; Renal Insufficiency, Chronic; Atrial Fibrillation
• Other Study ID Numbers: 9539; 2015-A00453-46 (Other Identifier: FRANCE: Agence Nationale de Sécurité du Médicament et des Produits de santé)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO