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CompletedNCT05232643PRESBUSUpdated Jun 2, 2026

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

An observational study in Non-Valvular Atrial Fibrillation (NVAF), sponsored by Bristol-Myers Squibb. Completed at 1 site in Italy. Open to participants aged 75 Years and older. Per ClinicalTrials.gov, last updated 2026-06-02.

Sponsored by Bristol-Myers Squibb · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
636
Ages
75 Years and older
Sex
All
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Study summary

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.

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Conditions studied

  • Non-Valvular Atrial Fibrillation (NVAF)

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Keywords

  • Atrial fibrillation
  • Oral Anticoagulants
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In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

This study's enrollment of 636 is above the median of 300 across 1,363 observational studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
75 Years and older
Sexes eligible
All
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.

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

Inclusion criteria

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

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
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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
636 participants (actual)
Patient registry
No

Groups and cohorts

  • Cohort 1

    Non-valvular atrial fibrillation (NVAF) participants administered oral anticoagulants (OAs)

  • Cohort 2

    Non-valvular atrial fibrillation (NVAF) participants not administered oral anticoagulants

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What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. Treatment switch: Change of antithrombotic drug (in terms of active principle) during the 12-month observational period

    Time frame: Up to approximately 12 months

  4. 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

  5. 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

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Study locations

1 site
  • Local Institution - 0001
    Milan, MI 20144, Italy
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05232643
Lead sponsor
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Feb 10, 2022
Start date
Jul 9, 2020
Primary completion
Nov 30, 2025
Completion
Nov 30, 2025
Last update
Jun 2, 2026

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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