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

NCT02464488 | Completed

• 1 other identifier: cfx-adage-2015
• Study Type: observational
• Target: 232
• Locations: 1 country
• Sites: 2

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.

Conditions

Atrial Fibrillation

Keywords

Anticoagulants; Factor Xa Inhibitors; Antithrombins; Pharmacokinetics; Aged, 80 years and older

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Thromboembolic events

  1 year

• Hemorrhagic events

  1 year

Study Arms (1)

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

Other: Plasma drug concentrations

Interventions

Plasma drug concentrations OTHER

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

Main cohort (only cohort of the study)

Eligibility Criteria

• Age: 80 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 80 years or older under treatment with dabigatran, rivaroxaban or apixaban because atrial fibrillation

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hôpital Charles Foix: lead
• University of Paris 5 - Rene Descartes: collaborator
• Sorbonne University: collaborator
• Assistance Publique - Hôpitaux de Paris: collaborator

Study Sites (2)

Hôpital Charles Foix

Ivry-sur-Seine, Île-de-France Region, 94205, France

Location

Hôpital Européen Georges Pompidou

Paris, Île-de-France Region, 75015, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Carmelo Lafuente, MD, PhD

  Hôpital Charles Foix, APHP, Université Paris 6 UPMC

  PRINCIPAL INVESTIGATOR

• Julien Le Guen, MD

  Hôpital Européen Georges Pompidou, APHP, Université Paris 5 Descartes

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 2, 2015
• First Posted: June 8, 2015
• Study Start: January 1, 2015
• Primary Completion: May 30, 2021
• Study Completion: August 25, 2021
• Last Updated: August 27, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)