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

Atrial Fibrillation Clinical Trial

— REINACO  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02964546
• Other study ID #: 9539
• Secondary ID: 2015-A00453-46
• Status: Terminated
• Start date: June 8, 2015
• Est. completion date: December 7, 2018

Study information

• Verified date: October 2021
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 116
• Est. completion date: December 7, 2018
• Est. primary completion date: November 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Chronic Kidney Disease
• Elderly Patients
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Other:
• Blood sample
2 additional tubes of blood samples are collected during a blood sample realized for the patient's care

Locations

Country	Name	City	State
France	University Hospital	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	renal function estimated by different glomerular filtration rate equations and by clearance of creatinine formula		At the inclusion
Secondary	plasmatic activity of direct oral anticoagulant at steady state residual time (anti-Xa or anti-IIa)		At the inclusion
Secondary	plasmatic concentration of direct oral anticoagulant at steady state residual time		At the inclusion
Secondary	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
Secondary	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