A Study Evaluating the Associations Between Clinical Characteristics and Use of Oral Anticoagulants in Italian Elderly Participants With Non-Valvular Atrial Fibrillation
Recruiting
- Conditions
- Non-Valvular Atrial Fibrillation (NVAF)
- Registration Number
- NCT05232643
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 720
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 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 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 net clinical outcomes defined as occurrence of stroke, systemic embolism, major bleeding or death Up to approximately 12 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Local Institution - 0001
🇮🇹Milano, MI, Italy