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OpenTrials
Completed

NCT Number: NCT05232643

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

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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Key information

Conditions

Non-valvular Atrial Fibrillation (NVAF) Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

75 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution - 0001

Milan, MI, 20144, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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.

Acronym: PRESBUS

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Feb 10, 2022
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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