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Completed

NCT Number: NCT05044533

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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution - 0001

Swansea, SA2 8PP, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Distribution of characteristics of AF participants: Quality of life (QoL) data

    Time frame: Up to 90 days

  2. Distribution of characteristics of AF participants: Impact of the anticoagulation treatment

    Time frame: Up to 90 days

Secondary outcomes

  1. Distribution of outcomes of AF participants: Timing of bleeding occurrence

    Time frame: Up to 90 days

  2. Distribution of outcomes of AF participants: Nature of the bleed

    Time frame: Up to 90 days

  3. Distribution of outcomes of AF participants: Current Bleeding treatment

    Time frame: Up to 90 days

  4. Distribution of outcomes of AF participants: Location of bleed

    Time frame: Up to 90 days

  5. Distribution of outcomes of AF participants: Documented cause of bleed

    Time frame: Up to 90 days

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Evaluating QUAlity of Life of AF Patients Following a Bleed (EQUAL-AF)

Acronym: EQUAL-AF

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 14, 2021
Registry last updated
Jun 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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