A Study Evaluating the Associations Between Clinical Characteristics and Use of Oral Anticoagulants in Italian Elderly Participants With Non-Valvular Atrial Fibrillation (PRESBUS)

November 29, 2023 updated by: Bristol-Myers Squibb

A Multicenter Prospective Observational Double Cohort Study to Evaluate the Associations Between Clinical Characteristics and Use of Oral Anticoagulants in Italian Elderly Patients Suffering From NVAF.

The purpose of this study is to provide real-world data useful to address the factors associated to the administration of oral anticoagulants in the elderly population affected by non-valvular atrial fibrillation (NVAF), in Italy, and it's persistence rate after one year.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

720

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: First line of the email MUST contain NCT # and Site #.

Study Contact Backup

  • Name: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,
  • Phone Number: please email:
  • Email: Clinical.Trials@bms.com

Study Locations

  • Italy
    • MI
      • Milano, MI, Italy, 20144
        • Recruiting
        • Local Institution - 0001
        • Contact:
          • Site 0001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study target population will be composed of elderly participants with diagnosis of Non-valvular atrial fibrillation (NVAF), managed in Italian geriatric departments/clinics.

Description

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Diagnosis of any type (e.g. persistent, permanent, paroxysmal) of Non-Valvular Atrial Fibrillation (NVAF) documented in the participant's medical chart based on electrocardiogram (ECG) results, or diagnosed at enrollment
  • Naïve to anticoagulant treatments, or not having received anticoagulant treatments during the 6 months prior to enrollment
  • Multidimensional geriatric assessment (MGA) performed at enrollment, or anyway no more than 3 months before in case of stable disease (i.e. no relevant events) in the previous 3 months

Exclusion Criteria:

  • Valvular atrial fibrillation (AF) due to artificial heart valve
  • Medical conditions (apart from NVAF) requiring anticoagulant therapy (such as deep vein thrombosis or pulmonary embolism)
  • Use of inappropriate direct-acting oral anticoagulant (DOAC) doses based on the current summary of product characteristics (SmPC) for any drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cohort 1
Non-valvular atrial fibrillation (NVAF) participants administered oral anticoagulants (OAs)
Cohort 2
Non-valvular atrial fibrillation (NVAF) participants not administered oral anticoagulants

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Anticoagulant (OA) cohort: Distribution of participants starting any type of anticoagulant direct-acting oral anticoagulant (DOAC) or Vitamin K antagonist (VKA) treatment
Time Frame: At Enrollment, up to 12 months
At Enrollment, up to 12 months
Non-Anticoagulant (Not-OA) cohort: Distribution of participants not starting any type of anticoagulant (DOAC) or (VKA) treatment
Time Frame: At Enrollment, up to 12 months
At Enrollment, up to 12 months
Treatment switch: Change of antithrombotic drug (in terms of active principle) during the 12-month observational period
Time Frame: Up to approximately 12 months
Up to approximately 12 months
Distribution of participants with persistence to the first treatment strategy: No switches nor interruptions of greater than 60 days in the first administered antithrombotic strategy (including no treatments) during the 12-month observational period
Time Frame: Up to approximately 12 months
Up to approximately 12 months
Distribution of participants with net clinical outcomes defined as occurrence of stroke, systemic embolism, major bleeding or death
Time Frame: Up to approximately 12 months
Up to approximately 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 9, 2020

Primary Completion (Estimated)

July 31, 2025

Study Completion (Estimated)

November 30, 2025

Study Registration Dates

First Submitted

January 31, 2022

First Submitted That Met QC Criteria

January 31, 2022

First Posted (Actual)

February 10, 2022

Study Record Updates

Last Update Posted (Estimated)

December 1, 2023

Last Update Submitted That Met QC Criteria

November 29, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV185-754

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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