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

Atrial Fibrillation Clinical Trial

— ADAGE  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02464488
• Other study ID #: cfx-adage-2015
• Status: Completed
• Start date: January 1, 2015
• Est. completion date: August 25, 2021

Study information

• Verified date: August 2021
• Source: Hôpital Charles Foix
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 232
• Est. completion date: August 25, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 80 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Other:
• Plasma drug concentrations
Measure of plasma concentrations of the anticoagulant drug taken by the patient

Locations

Country	Name	City	State
France	Hôpital Charles Foix	Ivry-sur-Seine	Île-de-France
France	Hôpital Européen Georges Pompidou	Paris	Île-de-France

Sponsors (4)

Lead Sponsor	Collaborator
Hôpital Charles Foix	Assistance Publique - Hôpitaux de Paris, Sorbonne University, University of Paris 5 - Rene Descartes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacologic parameters of new oral anticoagulants in elderly patients	Estimated area under the curve (AUC) of each of the 3 drugs studied	1 to 3 weeks
Secondary	Thromboembolic events	Any thromboembolic event (composite of ischemic stroke, systemic embolism or acute coronary syndrome) in the year after inclusion	1 year
Secondary	Hemorrhagic events	Major hemorrhagic events in the year after inclusion	1 year