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

NCT02964546 | Terminated

• 2 other identifiers: 95392015-A00453-46
• Study Type: observational
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Elderly Patients; Chronic Kidney Disease

Keywords

direct oral anticoagulants; atrial fibrillation; renal function; ckd-epi; plasmatic concentration

Outcome Measures

Primary Outcomes (1)

• renal function estimated by different glomerular filtration rate equations and by clearance of creatinine formula

  At the inclusion

Secondary Outcomes (4)

• 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

  At 1 month

• Number of haemorrhagic or thrombotic adverse events (serious or not) and unexpected events affecting patients

  At 6 months

Study Arms (1)

Blood sample

Other: Blood sample

Interventions

Blood sample OTHER

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

Blood sample

Eligibility Criteria

• Age: 65 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

University Hospital

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Atrial Fibrillation; Renal Insufficiency, Chronic

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2016
• First Posted: November 16, 2016
• Study Start: June 8, 2015
• Primary Completion: November 20, 2017
• Study Completion: December 7, 2018
• Last Updated: October 20, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)