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

Study Overview
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Brief Summary
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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.

Official Title
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Bleeding Events and Oral Anticoagulant Treatment in Non-Valvular Atrial Fibrillation (Heart-BEAT): A Cohort Study Based on CPRD-HES Data

Conditions
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Non-valvular Atrial Fibrillation

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a prescription for apixaban, rivaroxaban, dabigatran, or VKA during the study period Are ≥ 18 years of age at index date Have ≥ 12 months of computerised medical data prior to index date (date of OAC initiation) Have a record of AF on or ever prior to index date Exclusion Criteria: Have a record for a valvular condition that is considered causal for AF on or ever prior to index date 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) Have more than 1 OAC exposure which starts on the same date

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NVAF patients newly prescribed apixaban<br> | |
| NVAF patients newly prescribed rivaroxaban<br> | |
| NVAF patients newly prescribed dabigatran<br> | |
| NVAF patients newly prescribed VKA<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative incidence of clinically relevant bleeding events following treatment initiation among NVAF patients newly prescribed oral anticoagulants (OACs) |  | Approximately 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of clinical characteristics in patients with non-valvular atrial fibrillation (NVAF) newly prescribed oral anticoagulants (OACs) |  | At baseline | 
| Composite of patient demographics in patients with non-valvular atrial fibrillation (NVAF) newly prescribed oral anticoagulants (OACs) |  | At baseline | 
| Cumulative incidence of a major bleeding event following treatment initiation among NVAF patients newly prescribed oral anticoagulants (OACs) |  | Approximately 3 years | 
| Cumulative incidence of a thromboembolic event following treatment initiation among NVAF patients newly prescribed oral anticoagulants (OACs) |  | 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 | Approximately 3 years |