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

NCT ID: NCT02964546

Last Updated: 2021-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

116 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-08

Study Completion Date

2018-12-07

Brief Summary

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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

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Conditions

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Atrial Fibrillation Elderly Patients Chronic Kidney Disease

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Blood sample

Blood sample

Intervention Type OTHER

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

Interventions

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Blood sample

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospital

Montpellier, , France

Site Status

Countries

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France

Other Identifiers

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2015-A00453-46

Identifier Type: OTHER

Identifier Source: secondary_id

9539

Identifier Type: -

Identifier Source: org_study_id