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

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05044533

Collaborator

(none)

Enrollment

Location

5.1

Anticipated Duration (Months)

9.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 31, 2021

Anticipated Primary Completion Date :

Nov 1, 2021

Anticipated Study Completion Date :

Nov 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Cohort 1 Participants with atrial fibrillation (AF) experiencing a bleed

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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