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

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 Overview

• Status: Withdrawn
• Conditions: Non-valvular Atrial Fibrillation

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
NVAF patients newly prescribed apixaban
NVAF patients newly prescribed rivaroxaban
NVAF patients newly prescribed dabigatran
NVAF patients newly prescribed VKA

What is the study measuring?

Primary Outcome Measures

Outcome 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 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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Collaborators: Pfizer

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2016
• Primary Completion (Anticipated): August 31, 2018
• Study Completion (Anticipated): August 31, 2018

Study Registration Dates

• First Submitted: December 21, 2016
• First Submitted That Met QC Criteria: December 21, 2016
• First Posted (Estimate): December 26, 2016

Study Record Updates

• Last Update Posted (Actual): October 10, 2018
• Last Update Submitted That Met QC Criteria: October 9, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: CV185-491