We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Benefit/Risk in Real Life of New Oral Anticoagulants and Vitamin K Antagonists in Patients Aged 75 Years and Over Suffering From Non Valvular Atrial Fibrillation (nv AF) (Presage-Aco)

This study is not yet open for participant recruitment.
Verified September 2016 by Assistance Publique - Hôpitaux de Paris
Sponsor:
ClinicalTrials.gov Identifier:
NCT02906527
First Posted: September 20, 2016
Last Update Posted: September 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  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 (DOAC) and with anti vitamin K (VKA) in older adults (≥ 75 years) suffering from nvAF.

The study will be conducted in the French Health insurance database (SNIIRAM). Data of octo+ patients newly treated with an oral anticoagulant (VKA or DOAC) for non valvular atrial fibrillation (nv AF) will be collected from the first exposure of the patient to the drug of interest during the inclusion period to the end of the follow-up period (at least one year of follow-up for each patient)."


Condition Intervention
Non Valvular Atrial Fibrillation (nv AF) Drug: Non-exposed group Drug: Exposed group

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Benefit/Risk in Real Life of New Oral Anticoagulants and Vitamin K Antagonists in Patients Aged 75 Years and Over Suffering From Non Valvular Atrial Fibrillation (nv AF) : An Observational Study Conducted on the French Health Insurance Database (SNIIRAM)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Composite of major thromboembolic events, major bleeding events or death from any cause [ Time Frame: 2 years ]
    Major thromboembolic events include: Ischemic stroke, systemic or pulmonary embolism. Major bleeding is defined as a bleeding resulting in death or requiring hospital admission


Secondary Outcome Measures:
  • Potential risk factors for major bleeding and TE events in patients exposed to oral anticoagulant [ Time Frame: 1 year ]
  • Patterns of use of OAC [ Time Frame: 1 year ]
    Patterns of use will be described by : characteristics of the treated population (age, comorbidities leading to hospitalization), drug dose and regimen, time on treatment, concomitant drugs


Estimated Enrollment: 150000
Study Start Date: October 2016
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Non-exposed group
Non-exposed group / Patients receiving VKA
Drug: Non-exposed group
Non-exposed group / Patients receiving VKA
Other Name: Patients receiving VKA
Exposed group
Exposed group / Patients receiving DOAC
Drug: Exposed group
Exposed group / Patients receiving DOAC
Other Name: Patients receiving DOAC

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 valvular atrial fibrillation (nv AF) and without contraindication to anticoagulant therapy. Two drug classes are available to achieve this oral anticoagulation: the vitamin K antagonists (VKA, warfarin, fluinione and acenocoumarol) or the Direct Oral Anticoagulants (DOAC, dabigatran, rivaroxaban and apixaban). The data of evidence-based and post-marketing literature on the benefit/risk ratio of DOAC comparatively to VKA are limited, conflicting, potentially biased and finally inconclusive in this population. Nevertheless, this population is the most at risk for nv AF and the population with the highest risk of both AF-related thrombotic events and anticoagulant-related major bleedings.

  • 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 patients 75 years old or more suffering from nvAF. The main objective is to estimate and compare DOAC and VKA in terms of major bleeding, thrombotic events (TE) and death of all cause in 75 years old or more suffering from nv AF. The secondary objectives are to identify factors associated with the occurrence of these events, taking into account the type of anticoagulant, to identify factors associated with the occurrence of these events, taking into account switches from VKA to DOAC or DOAC to VKA, and to describe the utilization patterns of oral anticoagulants.
  • Design and statistical analyses: An observational study will be conducted in the French administrative database (SNIIRAM). The SNIIRAM database contains anonymous and prospectively recorded data about all beneficiaries' medical reimbursements including age, gender, long-term chronic disease (LTD), date of death, all out-hospital health-spending reimbursements and all patients' hospitalizations. We will include all octo+ patients they care for, newly treated ("new users") with an oral anticoagulant (VKA or DOAC) for nv AF, at the date of first prescription of oral anticoagulant. From the date, patients data will be collected during at least 2 years. To assess the principal endpoint, we will estimate the time between the date of inclusion and the date of occurrence of a major thromboembolic event, major bleeding event, or death from any cause, whichever comes first. Exposure will be considered as time-dependant. The total number of patients expected is 150 000."
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   75 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Beneficiaries aged ≥ 75 years old initiating a treatment by VKA or NOAC with an non vavular atrial fibrillation (nv AF).
Criteria

Inclusion Criteria:

  • Beneficiaries initiating a treatment by VKA or NOAC during the inclusion period (July 1, 2011 to December 31, 2014).
  • Aged ≥ 75 years old et the time of OAC initiation.
  • Presenting with an non valvular atrial fibrillation (nv AF).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02906527


Contacts
Contact: Dominique Bonnet-Zamponi, MD dominique.bonnet@aphp.fr

Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Dominique Bonnet-Zamponi, MD Assistance Publique - Hôpitaux de Paris
  More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02906527     History of Changes
Other Study ID Numbers: 16DBT-Presage-Aco
First Submitted: September 7, 2016
First Posted: September 20, 2016
Last Update Posted: September 20, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Cardiology
Oral anticoagulants
Risk and Benefit analysis
Health insurance databases
Safety
Elderly

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anticoagulants
Vitamin K
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs