Clinical trial NCT05232643: A Study Evaluating the Associations Between Clinical Characteristics and Use of Oral Anticoagulants in Italian Elderly Participants With Non-Valvular Atrial Fibrillation
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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non-Valvular Atrial Fibrillation (NVAF)
Keywords: Atrial fibrillation
Oral Anticoagulants
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2022-02-10
Enrollment: 720
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study target population will be composed of elderly participants with diagnosis of Non-valvular atrial fibrillation (NVAF), managed in Italian geriatric departments/clinics.

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.


Eligibility 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

Primary outcomes:
measure: Anticoagulant (OA) cohort: Distribution of participants starting any type of anticoagulant direct-acting oral anticoagulant (DOAC) or Vitamin K antagonist (VKA) treatment
timeFrame: At Enrollment, up to 12 months
measure: Non-Anticoagulant (Not-OA) cohort: Distribution of participants not starting any type of anticoagulant (DOAC) or (VKA) treatment
timeFrame: At Enrollment, up to 12 months
measure: Treatment switch: Change of antithrombotic drug (in terms of active principle) during the 12-month observational period
timeFrame: Up to approximately 12 months
measure: 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
timeFrame: Up to approximately 12 months
measure: Distribution of participants with net clinical outcomes defined as occurrence of stroke, systemic embolism, major bleeding or death
timeFrame: Up to approximately 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Local Institution - 0001
state: MI
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: