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

June 15, 2023 updated by: Bristol-Myers Squibb

Evaluating QUAlity of Life of AF Patients 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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Swansea, United Kingdom, SA2 8PP
        • Local Institution - 0001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients (≥18) who have Atrial fibrillation (AF) and are actively prescribed oral anticoagulant therapies (OATs) and have recently experienced bleeds, up to a maximum of 30 days prior to enrolment. No upper age limit will be applied, but patients must match all other inclusion/exclusion criteria.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 31, 2021

Primary Completion (Actual)

March 9, 2022

Study Completion (Actual)

March 9, 2022

Study Registration Dates

First Submitted

September 10, 2021

First Submitted That Met QC Criteria

September 10, 2021

First Posted (Actual)

September 14, 2021

Study Record Updates

Last Update Posted (Estimated)

June 16, 2023

Last Update Submitted That Met QC Criteria

June 15, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV185-770

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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