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

Overview

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.

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: August 31, 2018

Arms, Groups and Cohorts

  • NVAF patients newly prescribed apixaban
  • NVAF patients newly prescribed rivaroxaban
  • NVAF patients newly prescribed dabigatran
  • NVAF patients newly prescribed VKA

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Composite of clinical characteristics in patients with non-valvular atrial fibrillation (NVAF) newly prescribed oral anticoagulants (OACs)
    • Time Frame: At baseline
  • Composite of patient demographics in patients with non-valvular atrial fibrillation (NVAF) newly prescribed oral anticoagulants (OACs)
    • Time Frame: At baseline
  • Cumulative incidence of a major bleeding event following treatment initiation among NVAF patients newly prescribed oral anticoagulants (OACs)
    • Time Frame: Approximately 3 years
  • Cumulative incidence of a thromboembolic event following treatment initiation among NVAF patients newly prescribed oral anticoagulants (OACs)
    • Time Frame: Approximately 3 years
  • Composite of Healthcare resource utilization patients newly prescribed oral anticoagulants (OACs)
    • Time Frame: Approximately 3 years
    • Healthcare resource utilization corresponds to referrals, hospitalizations, prescriptions, and laboratory tests

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bristol-Myers Squibb
  • Collaborator
    • Pfizer
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Bristol-Myers Squibb, Study Director, Bristol-Myers Squibb

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