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

NCT02464488 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 232

Last updated 2021-08-27

No results posted yet for this study

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

Interventions

OTHER

Plasma drug concentrations

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

Sponsors & Collaborators

  • University of Paris 5 - Rene Descartes

    collaborator OTHER

  • Sorbonne University

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    collaborator OTHER

  • Hôpital Charles Foix

    lead OTHER

Principal Investigators

  • Carmelo Lafuente, MD, PhD · Hôpital Charles Foix, APHP, Université Paris 6 UPMC

  • Julien Le Guen, MD · Hôpital Européen Georges Pompidou, APHP, Université Paris 5 Descartes

Eligibility

Min Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-01
Primary Completion
2021-05-30
Completion
2021-08-25

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02464488 on ClinicalTrials.gov