A Study Evaluating Quality of Life for Participants With Atrial Fibrillation (AF) Following a Bleed (EQUAL-AF)

Overview

The purpose of this observational study is to identify participants with both minor and major bleeds as a result of anticoagulant treatment for AF and evaluating their QoL through both primary and secondary care settings.

Full Title of Study: “Evaluating QUAlity of Life of AF Patients Following a Bleed (EQUAL-AF)”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 1, 2021

Arms, Groups and Cohorts

  • Cohort 1
    • Participants with atrial fibrillation (AF) experiencing a bleed

Clinical Trial Outcome Measures

Primary Measures

  • Distribution of characteristics of AF participants: Quality of life (QoL) data
    • Time Frame: Up to 90 days
  • Distribution of characteristics of AF participants: Impact of the anticoagulation treatment
    • Time Frame: Up to 90 days

Secondary Measures

  • Distribution of outcomes of AF participants: Timing of bleeding occurrence
    • Time Frame: Up to 90 days
  • Distribution of outcomes of AF participants: Nature of the bleed
    • Time Frame: Up to 90 days
  • Distribution of outcomes of AF participants: Current Bleeding treatment
    • Time Frame: Up to 90 days
  • Distribution of outcomes of AF participants: Location of bleed
    • Time Frame: Up to 90 days
  • Distribution of outcomes of AF participants: Documented cause of bleed
    • Time Frame: Up to 90 days

Participating in This Clinical Trial

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria:

  • Adult patients (>= 18 years old) – Patients who can understand all study information and literature to provide fully informed consent – Atrial fibrillation (AF) as the primary diagnosis – Having a major or minor bleed up to a maximum of 30 days prior to point of enrolment – Receiving oral anticoagulation therapy for AF Exclusion Criteria:

  • Pregnant women – Patients with active cancer – Patients unable to consent for themselves – Patient on concomitant antiplatelet therapy

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bristol-Myers Squibb
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Bristol-Myers Squibb, Study Director, Bristol-Myers Squibb
  • Overall Contact(s)
    • Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,, please email:, Clinical.Trials@bms.com

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