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

Bristol-Myers Squibb0 sitesStarted: January 31, 2016Last updated: October 10, 2018

Conditions

Trial Snapshot

Phase: Not Applicable
Status: Withdrawn
Sponsor
Primary Endpoint: Cumulative incidence of clinically relevant bleeding events following treatment initiation among NVAF patients newly prescribed oral anticoagulants (OACs)

Study Overview Study Design Eligibility Criteria Outcomes Investigators Records & Identifiers Similar Trials

Study Overview

Brief Summary

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 Design

Study Type: Observational
Observational Model: Cohort
Time Perspective: Retrospective

Eligibility Criteria

Ages: 18 Years to — (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: No

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

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

Cumulative incidence of a major bleeding event following treatment initiation among NVAF patients newly prescribed oral anticoagulants (OACs)(Approximately 3 years)
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 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)(Approximately 3 years)

Investigators

Sponsor

Bristol-Myers Squibb

Sponsor Class

Industry

Responsible Party

Sponsor

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