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

Bristol-Myers Squibb636 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

636

Conditions

Non-Valvular Atrial Fibrillation (NVAF)

Eligibility

Sex: ALLMin age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Local Institution - 0001

Milan, MI, Italy

Outcomes

Primary Outcomes

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

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

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

Time frame: 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

Time frame: Up to approximately 12 months

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

Data from ClinicalTrials.gov

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