Clinical trial NCT03002740: Bleeding Events and Oral Anticoagulant Treatment in Non-Valvular Atrial Fibrillation
Official title: Bleeding Events and Oral Anticoagulant Treatment in Non-Valvular Atrial Fibrillation (Heart-BEAT): A Cohort Study Based on CPRD-HES Data
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Non-valvular Atrial Fibrillation
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2016-12-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with NVAF recorded in the UK Clinical Practice Research Datalink(CPRD) and Hospital Episode Statistics(HES) database, and who were newly prescribed with apixaban, rivaroxaban, dabigatran or VKA from 1st December 2012 and 31st December 2015 (or up to the most recent data available).

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.


Eligibility criteria: 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

Primary outcomes:
measure: Cumulative incidence of clinically relevant bleeding events following treatment initiation among NVAF patients newly prescribed oral anticoagulants (OACs)
timeFrame: Approximately 3 years
Secondary outcomes:
measure: Composite of clinical characteristics in patients with non-valvular atrial fibrillation (NVAF) newly prescribed oral anticoagulants (OACs)
timeFrame: At baseline
measure: Composite of patient demographics in patients with non-valvular atrial fibrillation (NVAF) newly prescribed oral anticoagulants (OACs)
timeFrame: At baseline
measure: Cumulative incidence of a major bleeding event following treatment initiation among NVAF patients newly prescribed oral anticoagulants (OACs)
timeFrame: Approximately 3 years
measure: Cumulative incidence of a thromboembolic event following treatment initiation among NVAF patients newly prescribed oral anticoagulants (OACs)
timeFrame: Approximately 3 years
measure: Composite of Healthcare resource utilization patients newly prescribed oral anticoagulants (OACs)
timeFrame: Approximately 3 years
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: