NCT05044533CompletedNot Applicable
Evaluating QUAlity of Life of AF Patients Following a Bleed (EQUAL-AF)
Bristol-Myers Squibb1 site in 1 country50 target enrollmentStarted: May 31, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Distribution of characteristics of AF participants: Quality of life (QoL) data
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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 Outcomes
- 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: Documented cause of 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)
Investigators
Study Sites (1)
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