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

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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03002740

Enrollment

Registered

2016-12-26

Start date

2016-01-31

Completion date

2018-08-31

Last updated

2018-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-valvular Atrial Fibrillation

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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)	Approximately 3 years	Healthcare resource utilization corresponds to referrals, hospitalizations, prescriptions, and laboratory tests

Outcome results