New Oral Direct Anticoagulants in Patients 80 Years Old and Over : a Population Pharmacokinetics Study

NCT ID: NCT02464488

Last Updated: 2021-08-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 232 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-01
• Study Completion Date: 2021-08-25

Brief Summary

Several new oral direct anticoagulants have been recently marketed. However, only a few, limited, studies have provided data about the pharmacology of new oral direct anticoagulants in older persons. This study try to better define wether the pharmacology of each of these 3 drugs (dabigatran, rivaroxaban and apixaban) is actually significantly different in very older patients (over 80) and to which extend. The investigators also try to characterize the main determinants (age, weight, renal function, co-morbidities, etc) of the variability observed between individuals in their response to he drugs studied. The method employed is a population pharmacokinetic/pharmacodynamic study.

Detailed Description

Several new oral direct anticoagulants have been recently marketed. A main indication for taking these drugs is atrial fibrillation and, in everyday practice, most patients with atrial fibrillation are older people. However, only a few, limited, studies have provided data about the pharmacology of new oral direct anticoagulants in older persons. Furthermore, this limited data strongly suggests that, in older patients, mean concentrations, overall exposition and half-live of these drugs are increased, as compared with younger people. This study try to better define wether the pharmacology of each of these 3 drugs (dabigatran, rivaroxaban and apixaban) is actually significantly different in very older patients (over 80) and to which extend. The investigators also try to characterize the main determinants (age, weight, renal function, co-morbidities, etc) of the variability observed between individuals in their response to he drugs studied. The method employed is a population pharmacokinetic/pharmacodynamic study. This is, many people (projected 225 patients) will have a few blood samples each and all data will be pooled using statistical methods specific to this kind of studies. Each patient will have one to five blood samples, taken at te same time that routine blood analysis, to determine plasma concentrations of the studied drug. In addition, patients will be followed for thrombotic and haemorrhagic events at 6 and 12 months.

Conditions

Atrial Fibrillation

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Main cohort (only cohort of the study)

Patients aged 80 years or older under treatment with dabigatran, rivaroxaban or apixaban because atrial fibrillation. All patients will have plasma drug concentrations measured and will be followed afterwards similarly

Plasma drug concentrations

Intervention Type: OTHER

Measure of plasma concentrations of the anticoagulant drug taken by the patient

Interventions

Plasma drug concentrations

Measure of plasma concentrations of the anticoagulant drug taken by the patient

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age 80 years or older
• Under treatment with dabigatran, rivaroxaban or apixaban
• For non-valvular atrial fibrillation

Exclusion Criteria

• Mechanical (non-biological) heart valve
• Any severe condition leading to a short estimated life expectance (a few months)

• Minimum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Paris 5 - Rene Descartes

OTHER

Sponsor Role: collaborator

Sorbonne University

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: collaborator

Hôpital Charles Foix

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carmelo Lafuente, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Charles Foix, APHP, Université Paris 6 UPMC

Julien Le Guen, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Européen Georges Pompidou, APHP, Université Paris 5 Descartes

Locations

Hôpital Charles Foix

Ivry-sur-Seine, Île-de-France Region, France

Hôpital Européen Georges Pompidou

Paris, Île-de-France Region, France

Countries

France

Other Identifiers

cfx-adage-2015

Identifier Type: -

Identifier Source: org_study_id