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

Non-Valvular Atrial Fibrillation (NVAF) Clinical Trial

— PRESBUS  

Official 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05232643
• Other study ID #: CV185-754
• Status: Recruiting
• Start date: July 9, 2020
• Est. completion date: November 30, 2025

Study information

• Verified date: November 2023
• Source: Bristol-Myers Squibb
• Contact: Recruiting sites have contact information. Please contact the si
• Phone: please email:
• Email: Clinical.Trials[@]bms.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 720
• Est. completion date: November 30, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Non-Valvular Atrial Fibrillation (NVAF)

Locations

Country	Name	City	State
Italy	Local Institution - 0001	Milano	MI

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Non-Anticoagulant (Not-OA) cohort: Distribution of participants not starting any type of anticoagulant (DOAC) or (VKA) treatment		At Enrollment, up to 12 months
Primary	Treatment switch: Change of antithrombotic drug (in terms of active principle) during the 12-month observational period		Up to approximately 12 months
Primary	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
Primary	Distribution of participants with net clinical outcomes defined as occurrence of stroke, systemic embolism, major bleeding or death		Up to approximately 12 months

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form