Bleeding Events and Oral Anticoagulant Treatment in Non-Valvular Atrial Fibrillation

Bristol-Myers Squibb

Overview

In a population of patients with non-valvular atrial fibrillation (NVAF), and treated with oral anticoagulants (OAC) in routine clinical practice in England, this study will describe patients treated with each OAC, and to estimate and compare event rates of treatment discontinuation, bleeding, and healthcare resource utilisation (HCRU) across OAC treatments.

Study Type

OBSERVATIONAL

Conditions

Non-valvular Atrial Fibrillation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Have a prescription for apixaban, rivaroxaban, dabigatran, or VKA during the study period 2. Are ≥ 18 years of age at index date 3. Have ≥ 12 months of computerised medical data prior to index date (date of OAC initiation) 4. Have a record of AF on or ever prior to index date Exclusion Criteria: 1. Have a record for a valvular condition that is considered causal for AF on or ever prior to index date 2. Have a history of the OACs which are prescribed during the study period (ie, history of index OAC, as patients need to be newly prescribed either apixaban, rivaroxaban, dabigatran, or VKA) 3. Have more than 1 OAC exposure which starts on the same date

Outcomes

Primary Outcomes

Cumulative incidence of clinically relevant bleeding events following treatment initiation among NVAF patients newly prescribed oral anticoagulants (OACs)

Time frame: Approximately 3 years

Secondary Outcomes

Composite of clinical characteristics in patients with non-valvular atrial fibrillation (NVAF) newly prescribed oral anticoagulants (OACs)

Time frame: At baseline

Composite of patient demographics in patients with non-valvular atrial fibrillation (NVAF) newly prescribed oral anticoagulants (OACs)

Time frame: At baseline

Cumulative incidence of a major bleeding event following treatment initiation among NVAF patients newly prescribed oral anticoagulants (OACs)

Time frame: Approximately 3 years

Cumulative incidence of a thromboembolic event following treatment initiation among NVAF patients newly prescribed oral anticoagulants (OACs)

Time frame: Approximately 3 years

Composite of Healthcare resource utilization patients newly prescribed oral anticoagulants (OACs)

Healthcare resource utilization corresponds to referrals, hospitalizations, prescriptions, and laboratory tests

Time frame: Approximately 3 years

Data from ClinicalTrials.gov

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