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

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status

Enrolling

Conditions

Non-Valvular Atrial Fibrillation (NVAF)

Study type

Observational

Funder types

Industry

Identifiers

NCT05232643
CV185-754

Details and patient eligibility

About

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.

Enrollment

720 estimated patients

Sex

All

Ages

75+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

720 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,; First line of the email MUST contain NCT # and Site #.

Data sourced from clinicaltrials.gov

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