NCT05232643

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
720

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 9, 2020

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 10, 2022

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2026

Completed
Last Updated

December 16, 2025

Status Verified

December 1, 2025

Enrollment Period

5.6 years

First QC Date

January 31, 2022

Last Update Submit

December 15, 2025

Conditions

Non-Valvular Atrial Fibrillation (NVAF)

Keywords

Atrial fibrillationOral Anticoagulants

Outcome Measures

Primary Outcomes (5)

  • Anticoagulant (OA) cohort: Distribution of participants starting any type of anticoagulant direct-acting oral anticoagulant (DOAC) or Vitamin K antagonist (VKA) treatment

    At Enrollment, up to 12 months

  • Non-Anticoagulant (Not-OA) cohort: Distribution of participants not starting any type of anticoagulant (DOAC) or (VKA) treatment

    At Enrollment, up to 12 months

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

    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

    Up to approximately 12 months

  • Distribution of participants with net clinical outcomes defined as occurrence of stroke, systemic embolism, major bleeding or death

    Up to approximately 12 months

Study Arms (2)

Cohort 1

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

Cohort 2

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

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Institution - 0001

Milan, MI, 20144, Italy

RECRUITING

Related Links

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Central Study Contacts

Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,

CONTACT

please email:Clinical.Trials@bms.com

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

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2022

First Posted

February 10, 2022

Study Start

July 9, 2020

Primary Completion

January 30, 2026

Study Completion

January 30, 2026

Last Updated

December 16, 2025

Record last verified: 2025-12

Locations

IT(1)