Clinical trial NCT02464488: New Oral Direct Anticoagulants in Patients 80 Years Old and Over : a Population Pharmacokinetics Study
Official title: Study of Interindividual Variability in the Response to New Oral Direct Anticoagulants (Dabigatran Etexilate, Rivaroxaban or Apixaban) in Patients 80 Years Old and Over, Using a Population Pharmacokinetics Approach.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: Anticoagulants
Factor Xa Inhibitors
Antithrombins
Pharmacokinetics
Aged, 80 years and older
Lead sponsor: Hôpital Charles Foix
Sponsor class: OTHER
Collaborators: name: University of Paris 5 - Rene Descartes
name: Sorbonne University
name: Assistance Publique - Hôpitaux de Paris
First posted: 2015-06-08
Enrollment: 232
Sex: ALL
Minimum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 80 years or older under treatment with dabigatran, rivaroxaban or apixaban because atrial fibrillation

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.

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)

Primary outcomes:
measure: Pharmacologic parameters of new oral anticoagulants in elderly patients
timeFrame: 1 to 3 weeks
Secondary outcomes:
measure: Thromboembolic events
timeFrame: 1 year
measure: Hemorrhagic events
timeFrame: 1 year
Other outcomes:
Locations:
city: Ivry-sur-Seine
country: France
facility: Hôpital Charles Foix
state: Île-de-France
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
state: Île-de-France
Study officials:
affiliation: Hôpital Charles Foix, APHP, Université Paris 6 UPMC
name: Carmelo Lafuente, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Européen Georges Pompidou, APHP, Université Paris 5 Descartes
name: Julien Le Guen, MD
role: PRINCIPAL_INVESTIGATOR
References: