Real-World Evidence of Anticoagulation Treatment In Non-Valvular Atrial Fibrillation In Italy

Bristol-Myers Squibb9,914 enrolled

Overview

To quantify rates of bleeding events and investigate the characteristics of prescribed patients, rates of bleeding events, persistence and healthcare resource utilization of Oral Anticoagulants (OACs) prescribed in routine clinical practice.

Study Type

OBSERVATIONAL

Enrollment

9,914

Conditions

Anticoagulation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * are at least 18 years of age at index date * Initiated new OAC therapy ( no previous prescriptions of the same index OAC in the last 12 months prior to the index date ) during the study period * Had at least 1 claim with diagnosis of AF anytime in their records Exclusion Criteria: * Have a record that is indicative of Valvular Atrial Fibrillation during this period * Have a history of the OACs prescribed during the study period as assessed during the period of data availability(i.e. history of index OAC, as patients need to be newly prescribed either apixaban, rivaroxaban, dabigatran or VKA) * Have more than one OAC exposure which starts on the same date

Locations (1)

Local Institution

Ravenna, Italy

Outcomes

Primary Outcomes

Incidence of clinically relevant bleeding events among Non-valvular atrial fibrillation (NVAF) patients following treatment initiation on an oral OAC in Italy

Time frame: Approximately 30 months

Secondary Outcomes

Distribution of patient demographics at the time of OAC initiation

Time frame: at baseline

Distribution of clinical characteristics at the time of OAC initiation

Time frame: at baseline

Composite of number and percentage of patients who are persistent with their newly prescribed OAC

Time frame: Approximately 30 months

Incidence of major bleeding events following treatment initiation among NVAF patients following treatment initiation on an oral OAC in Italy

Time frame: Approximately 30 months

Composite of number and percentage of patients with major bleeding events, thromboembolic events, or death while exposed to the newly prescribed OAC

Time frame: Approximately 30 months

Data from ClinicalTrials.gov

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