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Trial record 3 of 10 for:    presage

Benefit/Risk in Real Life of New Oral Anticoagulants and Vitamin K Antagonists in Patients Aged 80 Years and Over (PRESAGE-ACO)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2014 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT02286414
First received: November 5, 2014
Last updated: February 15, 2015
Last verified: October 2014
  Purpose

The aim of the study is to compare, in real life, the risk benefit (including both major bleeding and thrombotic events (TE) and death from any cause) associated with direct oral anticoagulants (DOA) and with anti vitamin K (VKA) in older adults (≥ 80 years) suffering from non valvular atrial fibrillation and living in community or nursing home settings.

An observational multicenter prospective inception cohort will be conducted within the PRESAGE-Network, an ongoing active network on drug safety in older adults in the Ile de France (IDF) area (Paris and its surroundings) involving a sample of general practitioners (GPs) and pharmacists, for an active surveillance of drug safety in older adults. GPs and pharmacists will prospectively include all octo+ patients they care for, newly treated with an oral anticoagulant (VKA or DOA) for nv AF and will follow them during 2 years.


Condition Intervention
Atrial Fibrillation
Drug: Direct oral antocoagulant: dabigatran, rivaroxaban, apixaban
Drug: Vitamin K antagonist: warfarin, fluindione, acenocoumarol

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Benefit/Risk in Real Life of New Oral Anticoagulants and Vitamin K Antagonists in the Treatment of Non Valvular Atrial Fibrillation in Patients Aged 80 Years and Over, Living at Home or in Nursing Home. A Prospective Cohort Study

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Composite of major bleeding events or thromboembolic events or death from any cause [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Major bleeding is defined as a bleeding resulting in death, requiring hospital admission, resulting in persistent or significant disability/incapacity, or being life threatening, according to the WHO definition of seriousness of Adverse Drug Reactions (ADRs). Thromboembolic events (TE) include: Ischemic stroke, systemic or pulmonary embolism.


Secondary Outcome Measures:
  • Major bleeding eventThromboembolic event [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Bleeding resulting in death, requiring hospital admission, resulting in persistent or significant disability/incapacity, or being life threatening, according to the WHO definition of seriousness of Adverse Drug Reactions (ADRs)

  • Thromboembolic event [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Ischemic stroke, systemic or pulmonary embolism

  • All adverse events [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Risk factors of TE events or major bleeding events [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Patterns of use of oral anticoagulants [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Pattern of use will be described by: characteristics of the treated population (age, comorbidities), drug indication, dose and regimen, time on treatment, reason of discontinuation where applicable, concomitant drugs


Estimated Enrollment: 2193
Study Start Date: February 2015
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Exposed group
Patients recieving direct oral anticoagulants (DOA)
Drug: Direct oral antocoagulant: dabigatran, rivaroxaban, apixaban
Exposure to direct oral antocoagulants
Non-exposed group
Patients recieving vitamine K antagonists (VKA)
Drug: Vitamin K antagonist: warfarin, fluindione, acenocoumarol
Exposure to vitamin K antagonist

Detailed Description:
  • Context: Oral anticoagulation is recommended for prevention of stroke and thrombo-embolic events in people aged 80 years and over (octo+) suffering from non vavular atrial fibrillation (nv AF) and without contraindication to anticoagulant therapy. Two drug classes are available to achieve this oral anticoagulation: the vitaminK antagonists (VKA, warfarin, fluindione and acenocoumarol) or the direct oral anticoagulants (DOA, dabigatran, rivaroxaban and apixaban). The data of evidence-based and post-marketing literature on the benefit/risk ratio of DOA comparatively to VKA are limited, conflicting, potentially biased and finally inconclusive in this population. Nevertheless, octo+ are the age bracket the most at risk for nv AF and the population with the highest risk of both anticoagulant-related major bleedings and AF-related thrombotic (TE) events.
  • Objectives: The aim of the study is to assess and compare the real benefits and harms of the two therapeutic strategies available in routine practice, for the anticoagulation in octo+ suffering from nvAF. The main objective is to estimate and compare a composite event including major bleeding, TE events and death from any cause of DOA and VKA in octo+ suffering from nv AF and living in community or nursing home settings. The secondary objectives are, in this population: to estimate and compare the composite event of each DOA (dabigatran, rivaroxaban, and apixaban) with the composite event of VKA, to estimate and compare the rate of occurrence of each component of the composite event in patients exposed to DOA as compared to patients exposed to VKA, to identify factors associated with the occurrence of major bleeding events and TE events in patients exposed to oral anticoagulants (OAC), to describe others adverse drug reactions (ADRs) (not serious bleeding and TE events; other serious or not serious ADRs) and to provide related rates in users of VKA and DOA as well as individual DOA, to describe the utilization patterns of oral anticoagulants.
  • Design: An observational multicenter prospective inception cohort will be conducted within the PRESAGE-Network, an ongoing active network on drug safety in older adults in the Ile de France (IDF) area (Paris and its surroundings) involving a sample of general practitioners (GPs) and pharmacists, for an active surveillance of drug safety in older adults.
  Eligibility

Ages Eligible for Study:   80 Years and older   (Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive patients aged 80 years or more, newly treated with oral anticoagulants for nv AF or for flutter, living in community or in nursing home
Criteria

Inclusion Criteria:

  • Aged 80 years and over
  • Newly treated with oral anticoagulants (DOA or VKA) for nv AF (whatever its type) or for flutter
  • Living in community or in nursing home
  • And consulting a general practionner (GP) and/or a pharmacist participating to the Presage network

Exclusion Criteria:

  • Opposition of the patient to the collection of his personal data
  • Follow-up deemed impossible
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02286414

Contacts
Contact: Florence Tubach, PhD +33-1-40-25-79-31 florence.tubach@bch.aphp.fr

Locations
France
Assistance Publique Hôpitaux de Paris Recruiting
Paris, France, 75018
Contact: Florence Tubach, MD, PhD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Florence Tubach, PhD Assistance Publique - Hôpitaux de Paris
  More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02286414     History of Changes
Other Study ID Numbers: AOM13472 
Study First Received: November 5, 2014
Last Updated: February 15, 2015
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Oral anticoagulants, Geriatrics, General Practitioner, Safety, Misuse

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Vitamins
Vitamin K
Fluindione
Apixaban
Warfarin
Rivaroxaban
Acenocoumarol
Dabigatran
Anticoagulants
Micronutrients
Growth Substances
Physiological Effects of Drugs
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifibrinolytic Agents
Fibrin Modulating Agents
Hemostatics
Coagulants

ClinicalTrials.gov processed this record on December 09, 2016