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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05044533

Acronym

EQUAL-AF

Enrollment

Registered

2021-09-14

Start date

2021-05-31

Completion date

2022-03-09

Last updated

2023-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

BMS-562247, Atrial Fibrillation, Oral Anticoagulant, Prospective Study, Quality of Life (QoL), United Kingdom

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

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

Secondary

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

Countries

United Kingdom

Outcome results