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)

NCT02906527 | Unknown

• 1 other identifier: 16DBT-Presage-Aco
• Study Type: observational
• Target: 150,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

"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)."

Conditions

Non Valvular Atrial Fibrillation (nv AF)

Keywords

Cardiology; Oral anticoagulants; Risk and Benefit analysis; Health insurance databases; Safety; Elderly

Outcome Measures

Primary Outcomes (1)

• Composite of major thromboembolic events, major bleeding events or death from any cause

  Major thromboembolic events include: Ischemic stroke, systemic or pulmonary embolism. Major bleeding is defined as a bleeding resulting in death or requiring hospital admission

  2 years

Secondary Outcomes (2)

• Potential risk factors for major bleeding and TE events in patients exposed to oral anticoagulant

  1 year

• Patterns of use of OAC

  1 year

Study Arms (2)

Non-exposed group

Non-exposed group / Patients receiving VKA

Drug: Non-exposed group

Exposed group

Exposed group / Patients receiving DOAC

Drug: Exposed group

Interventions

Non-exposed group DRUG

Non-exposed group / Patients receiving VKA

Also known as: Patients receiving VKA

Non-exposed group

Exposed group DRUG

Exposed group / Patients receiving DOAC

Also known as: Patients receiving DOAC

Exposed group

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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).

You may qualify if:

• Aged ≥ 75 years old et the time of OAC initiation.
• Presenting with an non valvular atrial fibrillation (nv AF).

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Officials

• Dominique Bonnet-Zamponi, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominique Bonnet-Zamponi, MD

CONTACT

dominique.bonnet@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2016
• First Posted: September 20, 2016
• Study Start: October 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: September 20, 2016

Record last verified: 2016-09